Phase 3
Completed N=37
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT04285580 ↗Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Jun 2023
Primary outcomePrimary: Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes — -3.7; -4.0; -2.5; -3.2 Millimeters of Mercury (mmHg)
◆ Published Evidence
Emerging
14citations · ~5 / year
Single Administration of Bimatoprost Implant: Effects on 24-Hour Intraocular Pressure and 1-Year Outcomes.
Summary
This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension
Linked Publications
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Single Administration of Bimatoprost Implant: Effects on 24-Hour Intraocular Pressure and 1-Year Outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes |
-3.7; -4.0; -2.5; -3.2; -2.9; -5.0 | — |
| PRIMARY Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs) |
12; 4 | — |
| SECONDARY Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes |
-1.6; 0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment
- Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months
Exclusion Criteria
- Current or anticipated enrollment in another investigational drug or device study
- Females who are pregnant, nursing, or planning a pregnancy during the study
Data sourced from ClinicalTrials.gov (NCT04285580) 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.