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NCT01110499 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
A Phase 2 study of Ocular Hypertension and Primary Open Angle Glaucoma, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
- 1
- Study location
NCT01110499: Completed Phase 2 study of Ocular Hypertension and Primary Open Angle Glaucoma, sponsored by Allergan.
NCT01110499 is a Phase 2 study of Ocular Hypertension and Primary Open Angle Glaucoma that has completed, run by Allergan. The registered enrollment target is 163 participants, below the 275-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01110499, a Phase 2 study of Ocular Hypertension and Primary Open Angle Glaucoma, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
- 1
- Study location
Study Summary
This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.
Primary Outcome
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
Conditions Studied
Interventions
- DRUG AGN-210961 Formulation 1
- DRUG AGN-210961 Formulation 2
- DRUG AGN-210961 Formulation 3
- DRUG AGN-210961 Formulation 4
- DRUG AGN-210961 Formulation 5
Study Locations (1)
California
- - Newport Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01110499 record still lists
NCT01110499 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 275-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (41% lower).
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 5 interventions - of which AGN-210961 Formulation 1 is the first listed.
NCT01110499 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01110499 about?
NCT01110499 is a clinical study titled "Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension". This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be sel...
What is the current status of trial NCT01110499?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2010-06. Estimated completion is 2011-06.
What conditions does trial NCT01110499 study?
This clinical trial studies the following conditions: Ocular Hypertension, Primary Open Angle Glaucoma.
What interventions are being tested in trial NCT01110499?
The interventions under investigation include: AGN-210961 Formulation 1 (DRUG), AGN-210961 Formulation 2 (DRUG), AGN-210961 Formulation 3 (DRUG), AGN-210961 Formulation 4 (DRUG), AGN-210961 Formulation 5 (DRUG).
Who is sponsoring clinical trial NCT01110499?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01110499 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01110499's enrollment target sits among peer trials
163 29th of 54 higher than 26 of 54 other Ocular Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ocular Hypertension 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.
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