Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Overview
- Phase
- Phase 1
- Intervention
- AGN-210669 ophthalmic solution, 0.075%
- Conditions
- Ocular Hypertension
- Sponsor
- Allergan
- Enrollment
- 172
- Primary Endpoint
- Change From Baseline in Average Eye Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
AGN-210669 ophthalmic solution, 0.075%
AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
Intervention: AGN-210669 ophthalmic solution, 0.075%
AGN-210669 ophthalmic solution, 0.05%
AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
Intervention: AGN-210669 ophthalmic solution, 0.05%
AGN-210669 ophthalmic solution, 0.025%
AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
Intervention: AGN-210669 ophthalmic solution, 0.025%
bimatoprost ophthalmic solution 0.03%
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
Intervention: bimatoprost ophthalmic solution 0.03%
AGN-210669 vehicle ophthalmic solution
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Intervention: AGN-210669 vehicle ophthalmic solution
Outcomes
Primary Outcomes
Change From Baseline in Average Eye Intraocular Pressure (IOP)
Time Frame: Baseline, Day 14 Hour 0
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
Secondary Outcomes
- Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP(Baseline, Day 14)