NCT00440336

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

February 24, 2007

Last Update Submit

February 28, 2007

Conditions

Open Angle Glaucoma

Keywords

IOPSLTLaserCosopt

Outcome Measures

Primary Outcomes (1)

  • Reduction in Intraocular Pressure

Interventions

CosoptDRUG
XalatanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subjects of either sex, of any race, eighteen years of age or older.
  • Diagnosis: Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Ocular Hypertension.
  • Mild to moderate glaucoma only: Pattern standard deviation (PSD); more than 1DB and less than 6 DB on Humphrey Visual Field.
  • Subject may be:
  • A newly diagnosed glaucoma or
  • A pre-existing glaucoma on not more than two topical antiglaucoma medications.
  • On no systemic medications known to increase IOP (e.g. steroids)
  • Visual acuity equal or better than 20/200 in the study eye
  • IOP less than 35 mm Hg in the study eye
  • No previous intraocular surgery within last 6 months, except laser PI greater than 3 months ago.

You may not qualify if:

  • Pigmentary OAG,
  • Proliferative diabetic retinopathy,
  • History of chronic or recurrent severe inflammatory eye disease (i.e. scleritis, uveitis, herpes keratitis),
  • Known allergy to COSOPT or any of Prostaglandin Analogues,
  • Chronic Obstructive Airways Disease (COPD),
  • Sinus bradycardia (heart rate \< 60 beats per minute),
  • Second or third-degree atrioventricular block,
  • Overt cardiac failure.
  • Pregnant and nursing mothers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Glaucoma Specialist

Reading, Massachusetts, 01867, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

dorzolamide-timolol combinationLatanoprost

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Mark Latina

    Advanced Glaucoma Specialist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Latina, MD

CONTACT

781-942-9876mark.latina2@verizon.net

Navin Prasad, MD

CONTACT

781-942-9876

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2007

First Posted

February 27, 2007

Study Start

October 1, 2006

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

US(1)