Phase 2
N=172
Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Ocular Hypertension · Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00809848 ↗Enrolled (actual)
172
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Change From Baseline in Average Eye Intraocular Pressure (IOP) — 25.350; 25.318; 25.341; 24.650 Millimeters of Mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGN-210669 ophthalmic solution, 0.075% (Drug); AGN-210669 ophthalmic solution, 0.05% (Drug); AGN-210669 ophthalmic solution, 0.025% (Drug); bimatoprost ophthalmic solution 0.03% (Drug); AGN-210669 vehicle ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2009
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 | — |
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.
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.