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The International Collaborative Exfoliation Syndrome Treatment Study

Primary Purpose

Exfoliation Syndrome, Glaucoma, Ocular Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Latanoprost with Pilocarpine vs Timolol or Cosopt
Sponsored by
The New York Eye & Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exfoliation Syndrome focused on measuring Exfoliation Syndrome, Latanoprost, Timolol, Pilocarpine

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Exfoliation syndrome in one or both eyes. Exfoliation material must be present on the anterior lens surface for diagnosis.
  2. 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.
  3. Age 50-80 years
  4. Open angles by gonioscopy

Exclusion Criteria:

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

Sites / Locations

  • New York Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

No Intervention

Arm Label

1

2

Arm Description

Latanoprost in combination with Pilocarpine

Timolol or Cosopt

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 5, 2008
Last Updated
December 5, 2008
Sponsor
The New York Eye & Ear Infirmary
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00804115
Brief Title
The International Collaborative Exfoliation Syndrome Treatment Study
Official Title
The International Collaborative Exfoliation Syndrome Treatment Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2000 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The New York Eye & Ear Infirmary
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Purpose: To compare the effect of treatment with latanoprost plus pilocarpine vs timolol or fixed combination timolol/dorzolamide (T/D) in eyes with exfoliation syndrome (XFS) and elevated IOP. Methods: A randomized, prospective, international, 12-center, two-year, open-label clinical trial was conducted. XFS patients aged 50-80 years with untreated IOP ≥22 mmHg and open angles with or without mild to moderate glaucomatous damage were included. One eligible eye per patient was randomly assigned to latanoprost and pilocarpine qhs to increase aqueous outflow and inhibit pupillary movement (group I), or to decrease aqueous production with timolol or T/D bid as needed for IOP control (group II). IOP, tonographic outflow facility, and trabecular pigmentation were measured every 6 months. Results: 277 (146 male) patients (mean age 69.1±6.8 yr, range 50-80 yr)' were enrolled between October 2000 and July 2003. XFS was unilateral in 118 (42.6%) and bilateral in 159 (57.4%) patients. Baseline TM pigmentation at the 6:00 angle was significantly associated with IOP (p=0.01). IOP reduction was 1.3 mmHg greater in Group I (n=145) than in Group II (n=132) (p=0.0003). Mean increase in outflow facility in Group I was 0.005 µl/mmHg/min vs 0 μl/mmHg/min in Group II (p<0.001). TM pigmentation at the 6:00 position at 24 months decreased from baseline more frequently in Group I than in Group II [34(26%) vs 20(16%)] and increased from baseline more frequently in Group II than in Group I [31(25%) vs 24(18%)]. Conclusions: Subjects in Group I had lower IOP, improved outflow facility and decreased TM pigmentation. Initial therapy to increase aqueous outflow and interfere with dispersion of exfoliation material and iris pigment by inhibiting pupillary movement is preferable to reducing aqueous secretion, which may be deleterious as primary treatment in this disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exfoliation Syndrome, Glaucoma, Ocular Hypertension
Keywords
Exfoliation Syndrome, Latanoprost, Timolol, Pilocarpine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Latanoprost in combination with Pilocarpine
Arm Title
2
Arm Type
No Intervention
Arm Description
Timolol or Cosopt
Intervention Type
Drug
Intervention Name(s)
Latanoprost with Pilocarpine vs Timolol or Cosopt
Other Intervention Name(s)
Timolol, Cosopt
Intervention Description
Timolol 0.5% bid or Cosopt bid Latanoprost 0.005% qhs Pilocarpine 2%
Primary Outcome Measure Information:
Title
Latanoprost combined with pilocarpine (L-PILO) should be as effective as timolol or Cosopt in lowering IOP
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ritch, MD
Organizational Affiliation
New York Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The International Collaborative Exfoliation Syndrome Treatment Study

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