The International Collaborative Exfoliation Syndrome Treatment Study

NCT00804115

Last updated date
Study Location
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Exfoliation Syndrome, Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Exfoliation Syndrome, Glaucoma, Ocular HypertensionThe International Collaborative Exfoliation Syndrome Treatment Study
NCT00804115
  1. New York, New York
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The International Collaborative Exfoliation Syndrome Treatment Study
Official Title  ICMJE The International Collaborative Exfoliation Syndrome Treatment Study
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 ?l/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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Exfoliation Syndrome
  • Glaucoma
  • Ocular Hypertension
Intervention  ICMJE Drug: Latanoprost with Pilocarpine vs Timolol or Cosopt
Timolol 0.5% bid or Cosopt bid Latanoprost 0.005% qhs Pilocarpine 2%
Other Names:
  • Timolol
  • Cosopt
Study Arms  ICMJE
  • No Intervention: 1
    Latanoprost in combination with Pilocarpine
    Intervention: Drug: Latanoprost with Pilocarpine vs Timolol or Cosopt
  • No Intervention: 2
    Timolol or Cosopt
    Intervention: Drug: Latanoprost with Pilocarpine vs Timolol or Cosopt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 5, 2008)
277
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00804115
Other Study ID Numbers  ICMJE 00.24
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Ritch, MD, Glaucoma Associates of New York
Study Sponsor  ICMJE The New York Eye & Ear Infirmary
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Robert Ritch, MDNew York Eye and Ear Infirmary
PRS Account The New York Eye & Ear Infirmary
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP