Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
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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 |
- 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) |
-
Drug: 0.005% Latanoprost dosed once.
- Xalatan
- Glaucoma
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 |
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| Contact: Padma Nanduri, MD | 858-699-4000 | drnanduri@envisioneye.com |
| Contact: Aaron Dyer | 858-699-4000 | aaron@envisioneye.com |
| 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 | |
| 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 May 19, 2013