Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

Glaucoma Clinical Trial

Official title:

Phase 2 Study of Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01426464
• Other study ID #: Brown Rabbit 2011-0001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 27, 2011
• Last updated: August 29, 2011
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: Nanduri, Padma, M.D., FACS
• Contact: Padma Nanduri, MD
• Phone: 858-699-4000
• Email: drnanduri[@]envisioneye.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• 0.005% Latanoprost dosed once.
0.005% Latanoprost dosed once. Placebo lotion dosed once.

Locations

Country	Name	City	State
United States	Eye Surgical and Medical Associates	Visalia	California

Sponsors (1)

Lead Sponsor	Collaborator
Nanduri, Padma, M.D., FACS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	Change in Intraocular Pressure from baseline.	Day one, every hour for twelve hours.	No
Primary	Intraocular Pressure	Change in Intraocular Pressure from baseline.	Day two twice, once in the AM, once in the PM.	No
Primary	Intraocular Pressure	Change in Intraocular Pressure from baseline.	Day nine, once.	No
Primary	Intraocular Pressure	Change in Intraocular Pressure from baseline.	Day sixteen, once.	No
Primary	Intraocular Pressure	Change in Intraocular Pressure from baseline.	Day twenty three, once.	No
Primary	Intraocular Pressure	Change in Intraocular Pressure from baseline.	Day thirty, once.	No