The International Collaborative Exfoliation Syndrome Treatment Study

NCT00804115 | Unknown DMC

• 1 other identifier: 00.24
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To determine the efficacy of treatment with latanoprost in combination with pilocarpine versus timolol or timolol/dorzolamide fixed combination (Timoptic or Cosopt) in eyes with XFS and elevated intraocular pressure (IOP). Methods: This is a randomized, open-label study to test the hypothesis that improving both pressure-dependent and pressure-independent aqueous outflow and minimizing iridolenticular friction will interfere with the progression of XFS, allow improvement in trabecular function, and be more effective over time than simply reducing aqueous formation. Randomization was performed across the centers, per patient rather than per eye to avoid any crossover effect caused by aqueous suppressants. Group I was treated with latanoprost and pilocarpine, both in the evening, and Group II with Timolol or Cosopt b.i.d. Only one eye per patient was randomized. Patients were followed for 2 years with assessment of IOP, visual field progression, tonographic outflow coefficient and trabecular pigmentation at the 6:00 and 12:00 position.

Conditions

Exfoliation Syndrome; Glaucoma; Ocular Hypertension

Keywords

Exfoliation Syndrome; Latanoprost; Timolol; Pilocarpine

Outcome Measures

Primary Outcomes (1)

• Latanoprost combined with pilocarpine (L-PILO) should be as effective as timolol or Cosopt in lowering IOP

  2 years

Study Arms (2)

1

NO INTERVENTION

Latanoprost in combination with Pilocarpine

Drug: Latanoprost with Pilocarpine vs Timolol or Cosopt

2

NO INTERVENTION

Timolol or Cosopt

Drug: Latanoprost with Pilocarpine vs Timolol or Cosopt

Interventions

Latanoprost with Pilocarpine vs Timolol or Cosopt DRUG

Timolol 0.5% bid or Cosopt bid Latanoprost 0.005% qhs Pilocarpine 2%

Also known as: Timolol, Cosopt

1; 2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exfoliation syndrome in one or both eyes. Exfoliation material must be present on the anterior lens surface for diagnosis.
• Untreated IOP greater than or equal to 22 mmHg in one or both eyes with or without mild to moderate glaucomatous damage and who, in the judgment of the investigator, can be safely washed off from current medical therapy.
• Age 50-80 years
• Open angles by gonioscopy

You may not qualify if:

• Age over 80 years
• Best corrected visual acuity less than 20/30
• Untreated IOP greater than 35 mmHg
• Currently taking systemic beta-blockers
• Glaucomatous damage sufficiently severe to prevent washout in the opinion of the examiner or visual field defect within 10 degrees of fixation
• Glaucoma other than exfoliation syndrome
• Absence of exfoliation material on the lens surface in the eye to be treated
• Known allergy or sensitivity to any of the study medications
• Ocular pathology that may interfere with the ability to obtain tonography, visual fields, or accurate IOP readings
• Angle-closure glaucoma
• Diabetic retinopathy
• Previous intraocular or laser surgery.
• Unwilling or unable to give consent
• Pregnant or lactating women

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead
• Pfizer: collaborator

Study Sites (1)

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Exfoliation Syndrome; Glaucoma; Ocular Hypertension

Interventions

Latanoprost; dorzolamide-timolol combination; Timolol

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Robert Ritch, MD

  New York Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: August 1, 2000
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2008
• Last Updated: December 8, 2008

Record last verified: 2008-12

Locations

US (1)