Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.005% Latanoprost that is applied to the outside of one eyelid.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nanduri, Padma, M.D., FACS
• Treatments: Latanoprost

Criteria

Inclusion Criteria:

• Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.

• Male or Female patients aged at least 18 years of age.

• Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.

• A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential.

• Best-Corrected Visual Acuity of 20/800 or better in both eyes

• Written informed consent.

• Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.

Exclusion Criteria:

• Uncontrolled glaucoma

• Glaucoma requiring more than a single agent for IOP control

• Patients with a corneal thickness greater then 620 micrometers

• Female patients who are pregnant, nursing, or planning a pregnancy during the study

• Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study

• Active intraocular inflammation

• Cystoid Macular Edema