Open Angle Glaucoma Clinical Trial
Official title:
Comparison of Efficacy of Prostaglandin Analogues (Xalatan) and Aqueous Suppressants (Cosopt) in Reducing Intraocular Pressure Following Selective Laser Trabeculoplasty in the Management of Open-Angle Glaucoma.
NCT number | NCT00440336 |
Other study ID # | 31663 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | February 24, 2007 |
Last updated | February 28, 2007 |
Start date | October 2006 |
WHAT IS THIS STUDY ABOUT? Glaucoma and ocular hypertension are chronic eye diseases that can
damage the optic nerve and lead to vision loss or blindness. The optic nerve acts like an
electric cable with over a million wires. This nerve is responsible for carrying images from
the eye to the brain. The way glaucoma and ocular hypertension cause blindness depends on
many factors, but the most important factor is the increased pressure inside the eye
(intraocular pressure).
There is no cure for glaucoma or ocular hypertension. However, lowering the pressure inside
the eye has been shown to slow the progression of disease. Intraocular pressure can be
lowered by glaucoma medication, laser treatment, or surgery.
You have open angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension.
Researchers want to find out more about how 2 drugs called Cosopt (dorzolamide hydrochloride
and timolol maleate) and Xalatan (latanoprost) can help people with these conditions.
Cosopt and Xalatan are both eye drops that are approved by the U.S. Food and Drug
Administration (FDA) to reduce intraocular pressure in people with open angle glaucoma and
ocular hypertension.
The study doctor will do a laser procedure called Selective Laser Trabeculoplasty (SLT) on
people in this study to help lower their intraocular pressure. The FDA has approved SLT to
treat open angle glaucoma and ocular hypertension.
Then the study doctor will ask some participants to use either Cosopt or Xalatan, if their
intraocular pressure is still too high 4 to 6 weeks after the SLT procedure. The study
doctor wants to see which of the 2 study drugs (Cosopt or Xalatan) is better at reducing
intraocular pressure after SLT.
It is planned that about 30 people with glaucoma or ocular hypertension who are at least 18
years old will be in this study. Out of the participants whose intraocular pressure is still
too high after SLT, half will use Cosopt and half will use Xalatan. You do not have to be in
this study to have SLT or to use Cosopt or Xalatan.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult subjects of either sex, of any race, eighteen years of age or older. 2. Diagnosis: Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Ocular Hypertension. 3. Mild to moderate glaucoma only: Pattern standard deviation (PSD); more than 1DB and less than 6 DB on Humphrey Visual Field. 4. Subject may be: - A newly diagnosed glaucoma or - A pre-existing glaucoma on not more than two topical antiglaucoma medications. 5. On no systemic medications known to increase IOP (e.g. steroids) 6. Visual acuity equal or better than 20/200 in the study eye 7. IOP less than 35 mm Hg in the study eye 8. No previous intraocular surgery within last 6 months, except laser PI greater than 3 months ago. Exclusion Criteria: 1. Pigmentary OAG, 2. Proliferative diabetic retinopathy, 3. History of chronic or recurrent severe inflammatory eye disease (i.e. scleritis, uveitis, herpes keratitis), 4. Known allergy to COSOPT or any of Prostaglandin Analogues, 5. Chronic Obstructive Airways Disease (COPD), 6. Sinus bradycardia (heart rate < 60 beats per minute), 7. Second or third-degree atrioventricular block, 8. Overt cardiac failure. 9. Pregnant and nursing mothers. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Advanced Glaucoma Specialist | Reading | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Advanced Glaucoma Specialists | Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Intraocular Pressure |
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