Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: 0.005% Latanoprost dosed once.||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Drug: 0.005% Latanoprost dosed once.
- Intraocular Pressure [ Time Frame: Day one, every hour for twelve hours. ]Change in Intraocular Pressure from baseline.
- Intraocular Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ]Change in Intraocular Pressure from baseline.
- Intraocular Pressure [ Time Frame: Day nine, once. ]Change in Intraocular Pressure from baseline.
- Intraocular Pressure [ Time Frame: Day sixteen, once. ]Change in Intraocular Pressure from baseline.
- Intraocular Pressure [ Time Frame: Day twenty three, once. ]Change in Intraocular Pressure from baseline.
- Intraocular Pressure [ Time Frame: Day thirty, once. ]Change in Intraocular Pressure from baseline.
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 ClinicalTrials.gov identifier (NCT number): NCT01426464
|Contact: Padma Nanduri, MDfirstname.lastname@example.org|
|Contact: Aaron Dyeremail@example.com|
|United States, California|
|Eye Surgical and Medical Associates||Not yet recruiting|
|Visalia, California, United States, 93277|
|Contact: Michael Boone, MD 559-627-9393 firstname.lastname@example.org|
|Contact: Amy Smith 559-627-9393 email@example.com|
|Sub-Investigator: Michael Boone, MD|
|Principal Investigator:||Padma Nanduri, MD|