Phase 3
Completed N=594
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
Glaucoma, Open-Angle · Hypertension
Source: ClinicalTrials.gov NCT02247804 ↗
Enrolled (actual)
594
Serious AEs
12.6%
Results posted
Apr 2020
Primary outcomePrimary: Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) — -6.46; -6.38; -6.05; -7.18 millimeters of mercury (mm Hg) — p=0.2950
◆ Published Evidence
Established
29citations · ~10 / year
Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies.
Summary
This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Linked Publications (2)
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Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies.
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Single Administration of Intracameral Bimatoprost Implant 10 µg in Patients with Open-Angle Glaucoma or Ocular Hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) |
-6.46; -6.38; -6.05; -7.18; -6.69; -6.48 | 0.2950 |
| PRIMARY IOP in the Study Eye at Week 2 (Hour 0) |
16.82; 17.02; 17.83 | 0.0033 sig |
| PRIMARY IOP in the Study Eye at Week 2 (Hour 2) |
16.48; 16.42; 17.33 | 0.0057 sig |
| PRIMARY IOP in the Study Eye at Week 6 (Hour 0) |
17.08; 16.88; 17.71 | 0.0547 |
| PRIMARY IOP in the Study Eye at Week 6 (Hour 2) |
16.62; 16.51; 17.16 | 0.0860 |
| PRIMARY IOP in the Study Eye at Week 12 (Hour 0) |
17.53; 17.61; 17.94 | 0.2950 |
| PRIMARY IOP in the Study Eye at Week 12 (Hour 2) |
16.81; 17.30; 17.51 | 0.0464 sig |
| SECONDARY Change From Baseline in IOP in the Study Eye |
-7.17; -6.97; -6.17; -7.52; -7.57; -6.67 | 0.0033 sig |
Eligibility Criteria
Inclusion Criteria
-Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
Exclusion Criteria
- Previous enrollment in another Allergan Bimatoprost SR Study.
- Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
- Anticipated need for laser eye surgery in either eye within the first 52 weeks of the study duration
- History of glaucoma surgery
Data sourced from ClinicalTrials.gov (NCT02247804) and the linked publication. 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. Informational only — not medical advice.