Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426464
Recruitment Status : Unknown
Verified August 2011 by Padma Nanduri, MD, FACS, Nanduri, Padma, M.D., FACS.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2011
Last Update Posted : August 31, 2011
Information provided by (Responsible Party):
Padma Nanduri, MD, FACS, Nanduri, Padma, M.D., FACS

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: 0.005% Latanoprost dosed once. Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
Study Start Date : September 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost
U.S. FDA Resources

Intervention Details:
    Drug: 0.005% Latanoprost dosed once.
    0.005% Latanoprost dosed once. Placebo lotion dosed once.
    Other Names:
    • Xalatan
    • Glaucoma

Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: Day one, every hour for twelve hours. ]
    Change in Intraocular Pressure from baseline.

  2. Intraocular Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ]
    Change in Intraocular Pressure from baseline.

  3. Intraocular Pressure [ Time Frame: Day nine, once. ]
    Change in Intraocular Pressure from baseline.

  4. Intraocular Pressure [ Time Frame: Day sixteen, once. ]
    Change in Intraocular Pressure from baseline.

  5. Intraocular Pressure [ Time Frame: Day twenty three, once. ]
    Change in Intraocular Pressure from baseline.

  6. Intraocular Pressure [ Time Frame: Day thirty, once. ]
    Change in Intraocular Pressure from baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426464

Contact: Padma Nanduri, MD 858-699-4000
Contact: Aaron Dyer 858-699-4000

United States, California
Eye Surgical and Medical Associates Not yet recruiting
Visalia, California, United States, 93277
Contact: Michael Boone, MD    559-627-9393   
Contact: Amy Smith    559-627-9393   
Sub-Investigator: Michael Boone, MD         
Sponsors and Collaborators
Nanduri, Padma, M.D., FACS
Principal Investigator: Padma Nanduri, MD

Responsible Party: Padma Nanduri, MD, FACS, Principal Investigator, Nanduri, Padma, M.D., FACS Identifier: NCT01426464     History of Changes
Other Study ID Numbers: Brown Rabbit 2011-0001
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: August 31, 2011
Last Verified: August 2011

Keywords provided by Padma Nanduri, MD, FACS, Nanduri, Padma, M.D., FACS:

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Antihypertensive Agents