Phase 3
Completed N=528
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-Angle · Hypertension
Source: ClinicalTrials.gov NCT02250651 ↗
Enrolled (actual)
528
Serious AEs
14.1%
Results posted
Jul 2021
Primary outcomePrimary: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) — -6.47; -6.18; -6.11; -7.16 millimeters of mercury (mmHg) — p=0.3738
◆ Published Evidence
Established
71citations · ~14 / year
Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2).
Summary
This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Linked Publications (3)
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Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 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 Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) |
-6.47; -6.18; -6.11; -7.16; -6.72; -6.36 | 0.3738 |
| PRIMARY IOP in the Study Eye at Week 2 (Hour 0) |
16.74; 16.92; 17.50 | 0.0382 sig |
| PRIMARY IOP in the Study Eye at Week 2 (Hour 2) |
16.09; 16.48; 17.19 | 0.0013 sig |
| PRIMARY IOP in the Study Eye at Week 6 (Hour 0) |
17.05; 16.93; 17.51 | 0.2304 |
| PRIMARY IOP in the Study Eye at Week 6 (Hour 2) |
16.13; 16.53; 17.18 | 0.0038 sig |
| PRIMARY IOP in the Study Eye at Week 12 (Hour 0) |
17.39; 17.68; 17.75 | 0.3738 |
| PRIMARY IOP in the Study Eye at Week 12 (Hour 2) |
16.70; 17.15; 17.50 | 0.0401 sig |
| SECONDARY Change From Baseline in IOP in the Study Eye |
-7.12; -6.94; -6.36; -7.77; -7.38; -6.67 | 0.0382 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 within the first 52 weeks of the study duration
- History of glaucoma surgery
Data sourced from ClinicalTrials.gov (NCT02250651) 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.