The International Collaborative Exfoliation Syndrome Treatment Study

NCT ID: NCT00804115

Last Updated: 2008-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 277 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2008-12-31

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.

Conditions

Exfoliation Syndrome; Glaucoma; Ocular Hypertension

Keywords

Exfoliation Syndrome; Latanoprost; Timolol; Pilocarpine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Latanoprost in combination with Pilocarpine

Group Type: NO_INTERVENTION

Latanoprost with Pilocarpine vs Timolol or Cosopt

Intervention Type: DRUG

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

2

Timolol or Cosopt

Group Type: NO_INTERVENTION

Latanoprost with Pilocarpine vs Timolol or Cosopt

Intervention Type: DRUG

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

Interventions

Latanoprost with Pilocarpine vs Timolol or Cosopt

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

Intervention Type: DRUG

Other Intervention Names

Timolol; Cosopt

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

The New York Eye & Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Glaucoma Associates of New York

Principal Investigators

Robert Ritch, MD

Role: PRINCIPAL_INVESTIGATOR

New York Eye and Ear Infirmary

Locations

New York Eye and Ear Infirmary

New York, New York, United States

Countries

United States

Other Identifiers

00.24

Identifier Type: -

Identifier Source: org_study_id