Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

Allergan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: AGN-210669 ophthalmic solution, 0.025%; Drug: AGN-210669 ophthalmic solution, 0.075%; Drug: AGN-210669 vehicle ophthalmic solution; Drug: AGN-210669 ophthalmic solution, 0.05%; Drug: bimatoprost ophthalmic solution 0.03%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809848

210669-003

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 5 patient groups, including a placebo group

AGN-210669 ophthalmic solution, 0.075%

Experimental group

Description:

AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.

Treatment:

Drug: AGN-210669 ophthalmic solution, 0.075%

AGN-210669 ophthalmic solution, 0.05%

Experimental group

Description:

AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.

Treatment:

Drug: AGN-210669 ophthalmic solution, 0.05%

AGN-210669 ophthalmic solution, 0.025%

Experimental group

Description:

AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.

Treatment:

Drug: AGN-210669 ophthalmic solution, 0.025%

bimatoprost ophthalmic solution 0.03%

Active Comparator group

Description:

Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.

Treatment:

Drug: bimatoprost ophthalmic solution 0.03%

AGN-210669 vehicle ophthalmic solution

Placebo Comparator group

Description:

AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Treatment:

Drug: AGN-210669 vehicle ophthalmic solution