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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.005% Latanoprost dosed once.
Sponsored by
Nanduri, Padma, M.D., FACS
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Xalatan, Transdermal

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eye Surgical and Medical Associates

Outcomes

Primary Outcome Measures

Intraocular Pressure
Change in Intraocular Pressure from baseline.
Intraocular Pressure
Change in Intraocular Pressure from baseline.
Intraocular Pressure
Change in Intraocular Pressure from baseline.
Intraocular Pressure
Change in Intraocular Pressure from baseline.
Intraocular Pressure
Change in Intraocular Pressure from baseline.
Intraocular Pressure
Change in Intraocular Pressure from baseline.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2011
Last Updated
August 29, 2011
Sponsor
Nanduri, Padma, M.D., FACS
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1. Study Identification

Unique Protocol Identification Number
NCT01426464
Brief Title
Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
Official Title
Phase 2 Study of Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanduri, Padma, M.D., FACS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Xalatan, Transdermal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
0.005% Latanoprost dosed once.
Other Intervention Name(s)
Xalatan, Glaucoma
Intervention Description
0.005% Latanoprost dosed once. Placebo lotion dosed once.
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
Change in Intraocular Pressure from baseline.
Time Frame
Day one, every hour for twelve hours.
Title
Intraocular Pressure
Description
Change in Intraocular Pressure from baseline.
Time Frame
Day two twice, once in the AM, once in the PM.
Title
Intraocular Pressure
Description
Change in Intraocular Pressure from baseline.
Time Frame
Day nine, once.
Title
Intraocular Pressure
Description
Change in Intraocular Pressure from baseline.
Time Frame
Day sixteen, once.
Title
Intraocular Pressure
Description
Change in Intraocular Pressure from baseline.
Time Frame
Day twenty three, once.
Title
Intraocular Pressure
Description
Change in Intraocular Pressure from baseline.
Time Frame
Day thirty, once.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Padma Nanduri, MD
Phone
858-699-4000
Email
drnanduri@envisioneye.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Dyer
Phone
858-699-4000
Email
aaron@envisioneye.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Padma Nanduri, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Surgical and Medical Associates
City
Visalia
State/Province
California
ZIP/Postal Code
93277
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Boone, MD
Phone
559-627-9393
Email
drboone@visaliaeyecare.com
First Name & Middle Initial & Last Name & Degree
Amy Smith
Phone
559-627-9393
Email
amys@visaliaeyecare.com
First Name & Middle Initial & Last Name & Degree
Michael Boone, MD

12. IPD Sharing Statement

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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

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