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NCT01157364 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
A Phase 1 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
NCT01157364: Completed Phase 1 study, sponsored by Allergan.
NCT01157364 is a Phase 1 study that has completed, run by Allergan. The registered enrollment target is 109 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01157364, a Phase 1 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
Primary Outcome
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Interventions
- DRUG bimatoprost 20 µg generation 2
- DRUG bimatoprost 15 µg generation 2
- DRUG bimatoprost 10 µg generation 2
- DRUG bimatoprost 6 µg generation 2
- DRUG bimatoprost 15 µg generation 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2010-09-23 |
| Est. Completion | 2016-08-09 |
| Phase | Phase 1 |
What the finished NCT01157364 record still lists
NCT01157364 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 5 interventions - of which bimatoprost 20 µg generation 2 is the first listed.
NCT01157364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01157364 about?
NCT01157364 is a clinical study titled "Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension". This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. St...
What is the current status of trial NCT01157364?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2010-09-23. Estimated completion is 2016-08-09.
What interventions are being tested in trial NCT01157364?
The interventions under investigation include: bimatoprost 20 µg generation 2 (DRUG), bimatoprost 15 µg generation 2 (DRUG), bimatoprost 10 µg generation 2 (DRUG), bimatoprost 6 µg generation 2 (DRUG), bimatoprost 15 µg generation 1 (DRUG).
Who is sponsoring clinical trial NCT01157364?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01157364's enrollment target sits among peer trials
109 522nd of 2000 higher than 1,478 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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