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Comparison of Efficacy of Two Groups of Glaucoma Drops (Xalatan vs.Cosopt) in Reducing Eye Pressure Following Laser (SLT)Treatment in the Management of Glaucoma.

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: NCT00440336
Recruitment Status : Unknown
Verified February 2007 by Advanced Glaucoma Specialists.
Recruitment status was:  Recruiting
First Posted : February 27, 2007
Last Update Posted : March 1, 2007
Merck Sharp & Dohme LLC
Information provided by:
Advanced Glaucoma Specialists

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Drug: Cosopt Drug: Xalatan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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.
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Primary Outcome Measures :
  1. Reduction in Intraocular Pressure

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00440336

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Contact: Mark Latina, MD 781-942-9876
Contact: Navin Prasad, MD 781-942-9876

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United States, Massachusetts
Advanced Glaucoma Specialist Recruiting
Reading, Massachusetts, United States, 01867
Sub-Investigator: Navin Prasad, MD         
Sponsors and Collaborators
Advanced Glaucoma Specialists
Merck Sharp & Dohme LLC
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Principal Investigator: Mark Latina Advanced Glaucoma Specialist
Layout table for additonal information Identifier: NCT00440336    
Other Study ID Numbers: 31663
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: March 1, 2007
Last Verified: February 2007
Keywords provided by Advanced Glaucoma Specialists:
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions