Phase 3
N=144
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma · Open-Angle Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02636946 ↗Enrolled (actual)
144
Serious AEs
12.0%
Results posted
Feb 2022
Primary outcome: Primary: Intraocular Pressure (IOP) at Baseline — 24.45; 24.38 millimeters of mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bimatoprost SR (Drug); Sham Bimatoprost SR (Drug); Selective Laser Trabeculoplasty (Procedure); Sham Selective Laser Trabeculoplasty (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) at Baseline |
24.45; 24.38 | — |
| PRIMARY Change From Baseline in IOP at Week 4 |
-6.28; -6.98 | 0.0166 sig |
| PRIMARY Change From Baseline in IOP at Week 12 |
-6.28; -6.81 | 0.0735 |
| PRIMARY Change From Baseline in Intraocular Pressure (IOP) at Week 24 |
-6.34; -6.59 | 0.3928 |
| SECONDARY Change From Baseline in IOP at Weeks 8, 15, and 20 |
-6.65; -7.09; -6.14; -5.36; -5.06; -4.29 | — |
| SECONDARY Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator |
410; 446 | — |
| SECONDARY Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP |
60.6; 92.7; 70.2; 78.0; 72.9; 80.0 | — |
Summary
This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
Exclusion Criteria
- Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
- Enrollment in other studies using Bimatoprost SR.
Data sourced from ClinicalTrials.gov (NCT02636946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.