The International Collaborative Exfoliation Syndrome Treatment Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by The New York Eye & Ear Infirmary.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00804115
First received: December 5, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Exfoliation Syndrome
Glaucoma
Ocular Hypertension
Drug: Latanoprost with Pilocarpine vs Timolol or Cosopt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The International Collaborative Exfoliation Syndrome Treatment Study

Resource links provided by NLM:


Further study details as provided by The New York Eye & Ear Infirmary:

Primary Outcome Measures:
  • Latanoprost combined with pilocarpine (L-PILO) should be as effective as timolol or Cosopt in lowering IOP [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 277
Study Start Date: August 2000
Estimated Study Completion Date: December 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Latanoprost in combination with Pilocarpine
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
No Intervention: 2
Timolol or Cosopt
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804115

Locations
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Pfizer
Investigators
Principal Investigator: Robert Ritch, MD New York Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Robert Ritch, MD, Glaucoma Associates of New York
ClinicalTrials.gov Identifier: NCT00804115     History of Changes
Other Study ID Numbers: 00.24
Study First Received: December 5, 2008
Last Updated: December 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The New York Eye & Ear Infirmary:
Exfoliation Syndrome
Latanoprost
Timolol
Pilocarpine

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Exfoliation Syndrome
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Iris Diseases
Uveal Diseases
Timolol
Latanoprost
Pilocarpine
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 20, 2014