Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

NCT01426464 | Unknown Phase 2

• 1 other identifier: Brown Rabbit 2011-0001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 outside of one eyelid.

Conditions

Glaucoma

Keywords

Glaucoma; Xalatan; Transdermal

Outcome Measures

Primary Outcomes (6)

• Intraocular Pressure

  Change in Intraocular Pressure from baseline.

  Day one, every hour for twelve hours.

• Intraocular Pressure

  Change in Intraocular Pressure from baseline.

  Day two twice, once in the AM, once in the PM.

• Intraocular Pressure

  Change in Intraocular Pressure from baseline.

  Day nine, once.

• Intraocular Pressure

  Change in Intraocular Pressure from baseline.

  Day sixteen, once.

• Intraocular Pressure

  Change in Intraocular Pressure from baseline.

  Day twenty three, once.

• Intraocular Pressure

  Change in Intraocular Pressure from baseline.

  Day thirty, once.

Interventions

0.005% Latanoprost dosed once. DRUG

0.005% Latanoprost dosed once. Placebo lotion dosed once.

Also known as: Xalatan, Glaucoma

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Nanduri, Padma, M.D., FACS: lead

Study Sites (1)

Eye Surgical and Medical Associates

Visalia, California, 93277, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Padma Nanduri, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Padma Nanduri, MD

CONTACT

858-699-4000; drnanduri@envisioneye.com

Aaron Dyer

CONTACT

858-699-4000; aaron@envisioneye.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2011
• First Posted: August 31, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 31, 2011

Record last verified: 2011-08

Locations

US (1)