Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT01426464

Run by

Nanduri, Padma, M.D., FACS

People needed

22

Starts

2011-09-01

Expected to finish

2011-12-01

Last updated by the study team

2011-08-31

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Eye Surgical and Medical Associates — Visalia, California, United States

Full record on ClinicalTrials.gov

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