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Biomedical subjects

Jeanette A Stewart

Publications and source records attributed to Jeanette A Stewart.

15 recordsLinked to original sources
PubMed2006

Mean intraocular pressure and progression based on corneal thickness in primary open-angle glaucoma.

PURPOSE: The aim of this study was to evaluate the association of corneal thickness on the incidence of glaucomatous progression at individual levels of intraocular pressure. METHODS: A retrospective, noninterventional evaluation of patients with primary open-angle glaucoma who were either stable over 5 years or had glaucomatous progression before 5 years of follow-up was performed. Each patient had central thickness corneal measurements documented. RESULTS: We included 310 patients in this study. Patients with thicker (at least 0.571 mm, n = 77) and mid-range corneas (0.511-0.570 mm, n = 177) progressed in 14% (n = 11) and 18% (n = 31) of cases, respectively. The progression rate for patients with a mean pressure of less than 17 mmHg in both groups was 12%-13%. In contrast, the progression rate in patients with 18 mmHg or higher was 23% and 16% in the mid-range and thick corneal groups, respectively. In patients with thinner corneas (equal to or less than 0.510 mm, n = 56), the progression rate was 32% (n = 18). The progression rate was 60% (12 of 20) with mean pressures of at least 18 mmHg or higher, but 18% with mean pressures equal to or less than 17 mmHg. Univariant (P = 0.05), but not multivariant, analysis showed that corneal thickness was a risk factor for progression. CONCLUSIONS: This study suggests that the reduction of intraocular pressure helps to prevent progression in patients with primary open-angle glaucoma. However, for patients with thinner corneas, pressure reduction may potentially be of even greater importance to help avoid glaucomatous progression. Future study should clarify potential variables associated with thin corneas and glaucomatous progression.

Cornea↗
PubMed2005

24-hour intraocular pressures with brimonidine purite versus dorzolamide added to latanoprost in primary open-angle glaucoma subjects.

OBJECTIVE: To evaluate the 24-hour efficacy of brimonidine purite versus dorzolamide, each added to latanoprost. DESIGN: Double-masked, 2-center, prospective, crossover comparison. PARTICIPANTS: Primary open-angle glaucoma (POAG) subjects. METHODS: Subjects were randomized to brimonidine purite or dorzolamide, each given twice daily, for the first 6-week treatment period after a 6-week latanoprost run-in. Subjects began the opposite treatment for the second 6-week period after a 6-week latanoprost-only treatment between periods. Intraocular pressure (IOP) was measured at 8 am, 12 pm, 4 pm, 8 pm, 12 am, 4 am, and 8 am at each baseline and at the end of each treatment period. This study provided an 80% power that a 1.5-mmHg difference could be excluded between groups if 27 subjects completed the study. A standard deviation (SD) of 2.8 mmHg was assumed. MAIN OUTCOME MEASURES: Twenty-four-hour efficacy of intraocular pressures of brimonidine purite versus dorzolamide, each added to latanoprost. RESULTS: In 31 completed subjects, the baseline mean diurnal 24-hour IOP (+/- SD) was 19.0+/-1.7 mmHg for brimonidine purite and 19.0+/-1.6 mmHg for dorzolamide (P = 0.52). The 8 am IOP after 6 weeks of therapy was 18.4+/-2.1 mmHg for brimonidine purite and 18.9+/-1.9 mmHg for dorzolamide (P = 0.40). The mean diurnal IOP was 16.9+/-1.5 mmHg for brimonidine purite and 16.8+/-1.5 mmHg for dorzolamide (P = 0.66). Dorzolamide caused a more bitter taste (P = 0.01) than brimonidine purite. CONCLUSIONS: This study suggests that brimonidine purite and dorzolamide, added to latanoprost, have similar efficacy and safety in POAG or ocular hypertensive subjects.

Aged↗
PubMed2004

The safety and efficacy of unoprostone 0.15% versus brimonidine 0.2%.

PURPOSE: To compare the efficacy and safety of unoprostone versus brimonidine both given twice daily in ocular hypertensive or primary open-angle glaucoma subjects. METHODS: After a 1-month washout period a baseline diurnal curve was measured every 2 hours from 08:00 hours (trough) to 20:00 hours in subjects with a trough intraocular pressure (IOP) and the pressure 24 mmHg. Qualified subjects were randomized to either brimonidine or unoprostone. After 6 weeks of treatment the period 1 diurnal curve was performed. Subjects were then switched to the opposite treatment for 6 weeks and the period 2 diurnal curve was performed. RESULTS: A total of 33 subjects were included in this study. In the brimonidine-treated group the trough IOP 20.1 +/- 2.8 mmHg was reduced from baseline up to 8 hours after dosing. In the unoprostone-treated group the trough IOP was 19.5 +/- 3.0 mmHg, which was statistically equal to that of brimonidine (p = 0.21), was reduced from baseline for 12 hours after dosing. Brimonidine decreased the IOP statistically more than unoprostone at 10:00 and 12:00 hours (p < 0.0001 and p = 0.02, respectively), while unoprostone reduced the IOP more than brimonidine at 18:00 and 20:00 hours (p = 0.002 and p = 0.05, respectively). Safety levels were similar between groups, but unoprostone caused more ocular stinging than brimonidine (p = 0.008). CONCLUSION: This study suggests that twice daily brimonidine demonstrates a statistically greater peak reduction in IOP than unoprostone. However, unoprostone, but not brimonidine, decreased IOP over the complete 12-hour daytime dosing cycle.

Antihypertensive Agents↗
PubMed2004

[Timolol 0.5%/dorzolamide 2% fixed combination versus timolol 0.5%/pilocarpine 2% fixed combination in primary open-angle glaucoma or ocular hypertensive patients].

PURPOSE: To establish the efficacy and safety of timolol 0.5%/dorzolamide 2% fixed combination versus timolol 0.5%/pilocarpine 2% fixed combination, each given twice daily, in primary open-angle glaucoma and ocular hypertensive patients. MATERIAL AND METHODS: In this prospective, multicenter, double-masked trial, 37 patients were treated twice daily with timolol for 4 weeks. Then, they were randomized to one of the treatment medications for 6 weeks, after which they were treated with timolol again for 2 weeks before placed on the opposite treatment medication for 6 weeks. RESULTS: A total of 36 patients completed the trial. The mean baseline intraocular pressure (IOP) was 22.3 +/- 3.7 mmHg. Following 6 weeks of treatment, the mean decrease of IOP was 18.0 +/- 2.2 mmHg for timolol/dorzolamide combination and 17.4 +/- 2.0 for timolol/pilocarpine combination. The mean diurnal curve IOP was 18.1 +/- 2.2 mmHg for timolol/dorzolamide group and 16.7 +/- 1.9 mmHg for timolol/pilocarpine group. These differences were statistically significant. Statistically more patients reported ocular pain and diminished vision during use of the timolol/pilocarpine combination. CONCLUSIONS: This study suggest that timolol 0.5%/pilocarpine 2% fixed combination can provide at least similar efficacious reduction in IOP as timolol 0.5 %/dorzolamide 2% fixed combination in patients with primary open-angle glaucoma and ocular hypertension.

Adrenergic beta-Antagonists↗
PubMed2003

A new measure of patient satisfaction with ocular hypotensive medications: the Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP).

PURPOSE: To validate the treatment-specific Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP). METHODS: Item content was developed by 4 heterogeneous patient focus groups (n = 32). Instrument validation involved 250 patients on ocular hypotensive medications recruited from ophthalmology practices in the Southern USA. Participants responded to demographic and test questions during a clinic visit. Standard psychometric analyses were performed on the resulting data. SAMPLE: Of the 412 patients screened, 253 consented to participate, and 250 provided complete datasets. The sample included 44% male (n = 109), 44% Black (n = 109) and 57% brown eyed (n = 142) participants, with a mean age of 64.6 years (SD 13.1) and a history of elevated IOP for an average of 8.4 yrs (SD 7.8). A majority was receiving monotherapy (60%, n = 151). RESULTS: A PC Factor analysis (w/ varimax rotation) of the 31 items yielded 5 factors (Eigenvalues > 1.0) explaining 70% of the total variance. Weaker and conceptually redundant items were removed and the remaining 15 items reanalyzed. The satisfaction factors were; Eye Irritation (EI; 4 items), Convenience of Use (CofU; 3 items), Ease of Use (EofU; 3 items), Hyperemia (HYP; 3 items), and Medication Effectiveness (EFF; 2 items). Chronbach's Alphas ranged from.80 to.86. Greater distributional skew was found for less common experiences (i.e., HYP & EI with 65% & 48.4% ceilings) than for more common experiences (i.e., EofU, CofU, EFF with 10.8%, 20.8% & 15.9% ceilings). TSS-IOP scales converged with conceptually related scales on a previously validated measure of treatment satisfaction, the TSQM (r =.36 to.77). Evidence of concurrent criterion-related validity was found. Patients' symptomatic ratings of eye irritation, hyperemia and difficulties using the medication correlated with satisfaction on these dimensions (r =.30-.56, all p <.001). Clinicians' ratings of IOP control, severity of side effects and problematic medication use correlated with patients' satisfaction scores on these dimensions (r =.13-.26, all p <.01). CONCLUSIONS: This study provides initial evidence that the TSS-IOP is a reliable and valid measure, assessing patients' satisfaction with ocular hypotensive medications.

Adult↗
PubMed2003

Timolol 0.5%/dorzolamide 2% fixed combination vs timolol maleate 0.5% and unoprostone 0.15% given twice daily to patients with primary open-angle glaucoma or ocular hypertension.

OBJECTIVE: To compare the efficacy and safety of timolol 0.5%/dorzolamide 2% fixed combination vs timolol maleate 0.5% and unoprostone 0.15% given twice daily. DESIGN: Prospective multicenter, randomized, double-masked, crossover comparison study. METHODS: Primary open-angle glaucoma or ocular hypertension patients were randomly assigned to one of the treatment groups for a 6-week treatment period and then crossed over to the opposite treatment. Diurnal curve testing was performed at 8:00 AM, 10:00 AM, 4:00 PM, 6:00 PM, and 8:00 PM at baseline and the end of each treatment period. The run-in medicine was timolol twice daily for 28 days. RESULTS: Thirty-two patients completed this trial. The baseline trough pressure was 24.3 +/- 3.0 mm Hg, and the diurnal curve was 23.4 +/- 3.2 mm Hg. For the fixed combination the treatment trough pressure was 20.8 +/- 4.1 mm Hg and the diurnal curve was 19.6 +/- 3.6 mm Hg, whereas timolol and unoprostone concomitant therapy showed a treatment trough pressure of 20.1 +/- 4.5 mm Hg and a diurnal pressure of 19.8 +/- 4.1 mm Hg. There was no significant difference between treatment groups at any time point, for the diurnal curve, or in the extended reduction from baseline. There was no difference between treatment groups regarding ocular and systemic unsolicited or solicited adverse events. Burning, stinging, and conjunctival hyperemia were the adverse events most noted. There were no serious adverse events during this trial. CONCLUSIONS: This study suggests that both timolol/dorzolamide 2% fixed combination and concomitant timolol maleate 0.5% and unoprostone 0.15% therapy provide similar efficacy and safety throughout the daytime diurnal curve.

Antihypertensive Agents↗
PubMed2003

Conjunctival hyperemia in healthy subjects after short-term dosing with latanoprost, bimatoprost, and travoprost.

PURPOSE: To evaluate conjunctival hyperemia after short-term use of latanoprost 0.005%, bimatoprost 0.03% and travoprost 0.004% in normal adults. DESIGN: Prospective, randomized, double-masked crossover active controlled comparison. METHODS: We evaluated conjunctival hyperemia by a standard photographic measure at the slit lamp and by anterior segment photographs in healthy subjects after dosing for 5 days with latanoprost, bimatoprost, or travoprost. Conjunctival hyperemia was evaluated at 24-hour trough (hour 0) and at hour 1 after dosing. Each subject was crossed over between periods after a 1-week washout interval. RESULTS: Twenty-eight subjects (mean age 26 +/- 9 years) completed this study. Several comparisons were noted to be significant between groups by slit-lamp biomicroscopy: first, at hour 0 latanoprost had significantly less hyperemia than bimatoprost; second, at hour 0 latanoprost showed significantly less change than bimatoprost compared with the study baseline (visit 2); third, at hour 1 latanoprost had significantly less hyperemia than travoprost; fourth, at hour 1 latanoprost demonstrated significantly less change from baseline in hyperemia than travoprost (visit 2); fifth, at hour 1 latanoprost had less change in hyperemia than bimatoprost or travoprost between the study and the nonstudy eye (P = .03); and last, at hour 1 latanoprost showed significantly less change than bimatoprost and travoprost compared with hour 0 (P = .04). Additionally, similar grades were observed by photographs with latanoprost demonstrating the lowest levels of hyperemia. Subjects complained less about other people noticing their red eye with latanoprost than bimatoprost or travoprost (P = .048). No serious adverse events were noted. CONCLUSIONS: This study suggests that latanoprost may cause significantly less short-term conjunctival hyperemia on average than bimatoprost or travoprost in healthy subjects.

Adult↗
PubMed2003

Efficacy and safety of timolol maleate/latanoprost fixed combination versus timolol maleate and brimonidine given twice daily.

PURPOSE: To evaluate the efficacy and safety of the timolol maleate/latanoprost fixed combination (TLFC) given once each evening versus brimonidine and timolol solution given twice daily as concomitant therapy in primary open-angle glaucoma or ocular hypertension patients. METHODS: Qualified subjects were begun on timolol alone twice daily for 1 month and then randomized to either TLFC or brimonidine and timolol concomitant therapy for 6 weeks. Patients were then switched to the other treatment regimen. Intraocular pressures (IOPs) were measured every 2 hours between 08 : 00 and 20 : 00 hours at baseline and at the end of periods 1 and 2. RESULTS: This study found that in 32 subjects the IOP diurnal curve on timolol alone (20.9 +/- 2.8 mmHg) decreased to 17.9 +/- 3.2 mmHg when patients were treated with TLFC and to 19.0 +/- 2.4 mmHg when patients were treated with brimonidine and timolol (p = 0.02). Intraocular pressures at individual time-points were statistically similar between the groups at the 08 : 00 trough and 2 and 4 hours after dosing. However, beyond 4 hours after dosing, TLFC-treated subjects demonstrated a trend towards lower IOPs at each 2-hour time-point that was not statistically significant after a Bonferroni correction (p <or= 0.05). The incidence of both solicited and unsolicited side-effects was similar between groups. CONCLUSION: This study suggests that TLFC given in the evening reduces the mean daytime diurnal IOP more than brimonidine and timolol given concomitantly twice daily.

Antihypertensive Agents↗
PubMed2003

Timolol 0.5%/dorzolamide 2% fixed combination versus timolol 0.5%/pilocarpine 2% fixed combination in primary open-angle glaucoma or ocular hypertensive patients.

PURPOSE: To establish the efficacy and safety of timolol maleate/dorzolamide fixed combination (TDFC) versus timolol maleate/pilocarpine fixed combination (TPFC), each given twice daily, in primary open-angle glaucoma or ocular hypertensive patients. METHODS: In this prospective, multicentred, double-masked trial, 37 patients were treated twice daily with timolol for 4 weeks. They were then randomized to one of the treatment medications for 6 weeks, after which they were treated with timolol again for 2 weeks before being placed on the opposite treatment medication for 6 weeks. RESULTS: A total of 36 patients completed the trial. Their mean baseline intraocular pressure (IOP) was 22.3 +/- 3.7 mmHg. Following 6 weeks of treatment, the mean trough (08.00 hours) IOP was 18.0 +/- 2.2 mmHg for TDFC and 17.4 +/- 2.0 mmHg for TPFC (p = 0.22). The mean diurnal curve IOP was 18.1 +/- 2.2 mmHg for TDFC and 16.7 +/- 1.9 mmHg for TPFC (p = 0.0007). At the remaining time-points (10.00, 18.00 and 20.00 hours), TPFC IOPs were statistically lower than TDFC IOPs (p < 0.03). There were statistically more unsolicited reports of vision change and ocular pain associated with TPFC (p = 0.04). Six patients were discontinued early from TPFC therapy (17%) versus two from TDFC (6%) (p = 0.13). CONCLUSIONS: This study suggests that TPFC can provide at least a similar efficacious reduction in IOP as TDFC in patients with primary open-angle glaucoma or ocular hypertension.

Antihypertensive Agents↗
PubMed2003

Acute and chronic ocular symptoms of dorzolamide 2% compared with placebo.

PURPOSE: To characterize and compare the ocular comfort and symptoms of dorzolamide and tear-replacement drops (placebo) in healthy volunteers. PATIENTS AND METHODS: Subjects were randomized in a double-masked fashion to receive each medicine for 6 days twice daily. Patients used a visual analog scale to assess the quality and intensity of pain temporally after initial (acute) dosing and after 6 days of chronic dosing. The visual analog scale, an objective measure of pain, allows a subject to grade their perceived intensity of pain on a line between 0 and 100 mm. RESULTS: Of 28 subjects enrolled in the study, 27 completed the protocol (1 subject was lost to follow-up). Dorzolamide demonstrated statistically greater peak ocular pain (21.4 +/- 22.3 mm) compared with placebo (1.9 +/- 4.4 mm) (P<0.0001) after chronic dosing. Time of mean peak pain for dorzolamide products was 15 seconds after dosing. The pain was statistically greater with dorzolamide compared with placebo for 50 seconds after dosing. On average the discomfort associated with dorzolamide lasted 38.9 +/- 17.9 seconds after dosing. The average pain per second for the first minute was 7.1 +/- 10.1 mm for dorzolamide. No differences in pain intensity were observed after acute and chronic dosing. The discomfort with dorzolamide was characterized after chronic dosing as "burning" (14.8 +/- 25.0 mm) and was associated with tearing (1.9 +/- 5.2 mm). CONCLUSION: Dorzolamide caused more ocular pain after instillation than placebo. However, the pain was characterized as mild and quickly resolved.

Acute Disease↗
PubMed2003

Corneal punctate staining with latanoprost, bimatoprost, and travoprost in healthy subjects.

PURPOSE: To evaluate short-term conjunctival and corneal punctate staining with latanoprost, bimatoprost, and travoprost in healthy individuals. MATERIALS AND METHODS: A single centered, active-controlled, three-period crossover comparison that evaluated conjunctival and corneal punctate staining, by grade and individual stains, in healthy subjects after dosing for five days in one eye with latanoprost, bimatoprost, or travoprost. Staining was evaluated at 24-hour trough (Hour 0) and at Hour 1 after dosing. RESULTS: Twenty-eight subjects completed this study. This study found that there was no significant difference by ANOVA for the number of individual corneal punctate stains either at trough (latanoprost 22.6 +/- 25.4, bimatoprost 16.8 +/- 25.6, and travoprost 21.1 +/- 26.0 mm Hg) (P = 0.33) or at 1 hour after dosing (latanoprost 23.8 +/- 26.3 bimatoprost 18.2 +/- 25.2, and travoprost 26.1 +/- 26.1 mm Hg) (P = 0.75) among treatment groups. No significant differences existed among treatment groups in the study eye compared with the non-study eye or to the study eye at Hour 0 or Hour 1 or to the period initiation or baseline visits (P > 0.05). Several significantly different comparisons, inconsistent in nature, were observed for the nasal and temporal conjunctival staining between the treatment groups. There were no differences in unsolicited or solicited adverse events between groups. CONCLUSION: This study suggests that, in healthy subjects after short-term treatment, latanoprost, bimatoprost, and travoprost demonstrate generally similar ocular surface epithelial staining characteristics.

Adult↗
PubMed2002

Comparison of the cardiovascular effects of unoprostone 0.15%, timolol 0.5% and placebo in healthy adults during exercise using a treadmill test.

PURPOSE: To compare the cardiovascular effects of unoprostone 0.15%, timolol 0.5% and placebo in healthy adults during exercise using a treadmill test. METHODS: Thirty subjects aged 18-37 years (mean age = 24.1 years) were randomized to one of six treatment sequences in a three-treatment, three-period crossover study (William's design). Study medication was instilled b.i.d. for 5 days before visits 2, 3, and 4. Between treatments, study medication was washed out for 9-10 days. Each subject underwent a submaximal treadmill test at visits 2 through 4, 15 min after dosing. RESULTS: After 15 min of exercise, average heart rates were 143.1 +/- 21.2, 134.5 +/- 20.0 and 145.4 +/- 20.8 bpm for the unoprostone, timolol and placebo treatments, respectively. At no timepoint was there a statistically significant difference between the unoprostone and placebo treatments (p > 0.05). Beginning with the second minute of exercise, timolol produced a greater decrease in heart rate at all timepoints from placebo than unoprostone (p < 0.05). No consistent differences in systolic or diastolic blood pressure were observed between drug treatments (p > 0.05). CONCLUSIONS: Unlike timolol, unoprostone 0.15% does not reduce exercise-induced heart rate, indicating a lack of clinical effect on systemic beta-adrenergic receptors in young and healthy subjects.

Adolescent↗
PubMed2002

Cardiovascular effects of timolol maleate, brimonidine or brimonidine/timolol maleate in concomitant therapy.

PURPOSE: To examine the influence on maximal exercise performance in young healthy volunteers of timolol 0.5%, brimonidine 0.2% or placebo versus brimonidine 0.2% and timolol 0.5% used concomitantly. METHODS: The subjects in this prospective, double-masked, crossover comparison were dosed 15 min prior to treadmill testing. A period of 1 week was allowed between tests. RESULTS: The 20 subjects who completed the trials (average age 24.5 +/- 7.4) had a mean maximum exercise heart rate of 196 +/- 12 bpm for placebo, 182 +/- 13 bpm for timolol, 187 +/- 10 bpm for brimonidine, and 186 +/- 11 bpm for timolol/brimonidine concomitant therapy (p < 0.005). During recovery, the placebo group demonstrated a statistically higher systolic blood pressure (min 6) and pulse (mins 2 and 4) (p < 0.01). In addition, subjects treated with timolol/brimonidine demonstrated more premature contractions (atrial or ventricular) overall during exercise and recovery (p = 0.01). The brimonidine and concomitant treatment groups showed the greatest number of adverse events per subject, the most common of which were dizziness and fatigue (p = 0.031). CONCLUSION: This study suggests that both timolol and brimonidine, used alone and concomitantly, cause cardiovascular effects consistent with their pharmacology.

Adrenergic alpha-Agonists↗
PubMed2002

The safety and efficacy of timolol 0.5% in xanthan gum versus timolol gel forming solution 0.5%.

PURPOSE: To evaluate the efficacy and safety of timolol maleate 0.5% gel forming solution (TXE, Merck) versus timolol maleate 0.5% gel forming solution (TXG, Falcon) in primary open-angle glaucoma and ocular hypertension patients. METHODS: Following a washout period patients were randomly begun on either TXE or TXG each given once each morning for six weeks (Period 1). Patients then were crossed over to the opposite medicine for Period 2. Following each 6-week treatment period the intraocular pressure was obtained at 08:00 trough and +2 and +8 hours post-dosing. Anterior segment staining and photography were performed to assess surface irritation. RESULTS: Thirty-two patients were enrolled in this study; 28 completed. The diurnal intraocular pressure as well as the 08:00 trough and +2 hour post dosing pressures were statistically equal between groups, although a trend to a lower mean pressure was observed in the TXE (17.9 +/- 3.2 mm Hg) compared to the TXG (18.6 +/- 3.4 mm Hg) group. However, eight hours after dosing the pressure was 17.5 +/- 3.2 mm Hg in the TXE group and 18.9 +/- 3.3 mm Hg in the TXG group (P = 0.0019). Safety was similar between groups, including corneal and conjunctival staining, conjunctival hyperemia graded by anterior segment photography and at the slit lamp, and unsolicited and solicited side effects. Vision recovery after instillation was similar between groups. CONCLUSIONS: TXE demonstrates a lower intraocular pressure eight hours after dosing than does TXG, but safety appears similar between products.

Adrenergic beta-Antagonists↗