Status:
UNKNOWN
Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
Lead Sponsor:
Nanduri, Padma, M.D., FACS
Conditions:
Glaucoma
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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 outsi...
Detailed Description
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01426464
Start Date
September 1 2011
End Date
December 1 2011
Last Update
August 31 2011
Active Locations (1)
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1
Eye Surgical and Medical Associates
Visalia, California, United States, 93277