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 recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Advanced Glaucoma Specialists.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Advanced Glaucoma Specialists
ClinicalTrials.gov Identifier:
NCT00440336
First received: February 24, 2007
Last updated: February 28, 2007
Last verified: February 2007
  Purpose

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 Intervention
Open Angle Glaucoma
Drug: Cosopt
Drug: Xalatan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Advanced Glaucoma Specialists:

Primary Outcome Measures:
  • Reduction in Intraocular Pressure

Estimated Enrollment: 30
Study Start Date: October 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440336

Contacts
Contact: Mark Latina, MD 781-942-9876 mark.latina2@verizon.net
Contact: Navin Prasad, MD 781-942-9876

Locations
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 Corp.
Investigators
Principal Investigator: Mark Latina Advanced Glaucoma Specialist
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00440336     History of Changes
Other Study ID Numbers: 31663
Study First Received: February 24, 2007
Last Updated: February 28, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Glaucoma Specialists:
IOP
SLT
Laser
Cosopt

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

ClinicalTrials.gov processed this record on April 22, 2014