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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

NCT ID: NCT01426464

Last Updated: 2011-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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 goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.

Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.

Conditions

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Glaucoma

Keywords

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Glaucoma Xalatan Transdermal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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0.005% Latanoprost dosed once.

0.005% Latanoprost dosed once. Placebo lotion dosed once.

Intervention Type DRUG

Other Intervention Names

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Xalatan Glaucoma

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanduri, Padma, M.D., FACS

INDIV

Sponsor Role lead

Responsible Party

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Padma Nanduri, MD, FACS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Padma Nanduri, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Eye Surgical and Medical Associates

Visalia, California, United States

Site Status

Countries

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United States

Central Contacts

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Padma Nanduri, MD

Role: CONTACT

Phone: 858-699-4000

Email: [email protected]

Aaron Dyer

Role: CONTACT

Phone: 858-699-4000

Email: [email protected]

Facility Contacts

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Michael Boone, MD

Role: primary

Amy Smith

Role: backup

Other Identifiers

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Brown Rabbit 2011-0001

Identifier Type: -

Identifier Source: org_study_id