Phase 2
Completed N=172
Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Source: ClinicalTrials.gov NCT00809848 ↗Enrolled (actual)
172
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Change From Baseline in Average Eye Intraocular Pressure (IOP) — 25.350; 25.318; 25.341; 24.650 Millimeters of Mercury (mmHg)
Summary
The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Eye Intraocular Pressure (IOP) |
25.350; 25.318; 25.341; 24.650; 25.507; -5.807 | — |
| SECONDARY Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP |
62.9; 57.6; 30.3; 63.3; 2.8 | — |
Eligibility Criteria
Inclusion Criteria
- Ocular hypertension or primary open-angle glaucoma
- Females of non-childbearing potential
- Subject requires IOP-lowering therapy in both eyes
- IOP ≥ 22 mm Hg and ≤ 34 mm Hg
- Has a visual acuity score of 20/100 or better in each eye
Exclusion Criteria
- Uncontrolled systemic disease
- Active ocular disease
- Alteration of existing chronic systemic medications
- Known allergy or sensitivity to the study medications
- Ophthalmic corticosteroids
- Visual field loss which in the opinion of the investigator is functionally significant
- History of ocular laser, intraocular surgery, or refractive surgery
Data sourced from ClinicalTrials.gov (NCT00809848). 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.