Phase 3
N=240
Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02507687 ↗Enrolled (actual)
240
Serious AEs
9.9%
Results posted
May 2024
Primary outcome: Primary: Change From Baseline in Intraocular Pressure at Week 4 — -6.2; -6.8 mmHg — p=0.0231
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
- AbbVie
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intraocular Pressure at Week 4 |
-6.2; -6.8 | 0.0231 sig |
| PRIMARY Change From Baseline in Intraocular Pressure at Week 12 |
-6.4; -6.9 | 0.1615 |
| PRIMARY Change From Baseline in Intraocular Pressure at Week 24 |
-6.5; -6.9 | 0.1673 |
| SECONDARY Time to Initial Use of Non-study IOP-lowering Treatment |
263; 276; NA; 732; NA; NA | — |
| SECONDARY Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle |
59.1; 86.6; 68.5; 71.2; 64.0; 75.3 | — |
| SECONDARY Change From Baseline in IOP at Weeks 8, 15, and 20 |
25.1; 25.2; -6.1; -6.8; -6.0; -6.0 | — |
Summary
This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients 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.
- In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
- In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.
Exclusion Criteria
- History of previous laser trabeculoplasty
- History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
- Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
- Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.
Data sourced from ClinicalTrials.gov (NCT02507687). 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.