Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Nanduri, Padma, M.D., FACS.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Padma Nanduri, MD, FACS, Nanduri, Padma, M.D., FACS
ClinicalTrials.gov Identifier:
NCT01426464
First received: August 27, 2011
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Glaucoma
Drug: 0.005% Latanoprost dosed once.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

Resource links provided by NLM:


Further study details as provided by Nanduri, Padma, M.D., FACS:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: Day one, every hour for twelve hours. ] [ Designated as safety issue: No ]
    Change in Intraocular Pressure from baseline.

  • Intraocular Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ] [ Designated as safety issue: No ]
    Change in Intraocular Pressure from baseline.

  • Intraocular Pressure [ Time Frame: Day nine, once. ] [ Designated as safety issue: No ]
    Change in Intraocular Pressure from baseline.

  • Intraocular Pressure [ Time Frame: Day sixteen, once. ] [ Designated as safety issue: No ]
    Change in Intraocular Pressure from baseline.

  • Intraocular Pressure [ Time Frame: Day twenty three, once. ] [ Designated as safety issue: No ]
    Change in Intraocular Pressure from baseline.

  • Intraocular Pressure [ Time Frame: Day thirty, once. ] [ Designated as safety issue: No ]
    Change in Intraocular Pressure from baseline.


Estimated Enrollment: 22
Study Start Date: September 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 0.005% Latanoprost dosed once.
    0.005% Latanoprost dosed once. Placebo lotion dosed once.
    Other Names:
    • Xalatan
    • Glaucoma
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426464

Contacts
Contact: Padma Nanduri, MD 858-699-4000 drnanduri@envisioneye.com
Contact: Aaron Dyer 858-699-4000 aaron@envisioneye.com

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

No publications provided

Responsible Party: Padma Nanduri, MD, FACS, Principal Investigator, Nanduri, Padma, M.D., FACS
ClinicalTrials.gov Identifier: NCT01426464     History of Changes
Other Study ID Numbers: Brown Rabbit 2011-0001
Study First Received: August 27, 2011
Last Updated: August 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nanduri, Padma, M.D., FACS:
Glaucoma
Xalatan
Transdermal

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014