Phase 2
Completed N=163
Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT01110499 ↗Enrolled (actual)
163
Serious AEs
0.8%
Results posted
Aug 2014
Primary outcomePrimary: Part 1: Change From Baseline in Intraocular Pressure (IOP) — 25.4; 25.6; 24.3; 26.7 Millimeters of Mercury (mmHg)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Change From Baseline in Intraocular Pressure (IOP) |
25.4; 25.6; 24.3; 26.7; 24.4; 25.3 | — |
| PRIMARY Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) |
24.63; 24.62; 23.40; 23.70; 22.25; 22.51 | — |
Eligibility Criteria
Inclusion Criteria
- Ocular hypertension or primary open-angle glaucoma in each eye
Exclusion Criteria
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Anticipated use of artificial tears during study
- Contraindication to pupil dilatation
Data sourced from ClinicalTrials.gov (NCT01110499). 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.