Overview

Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension

Status:
Terminated

Trial end date:
2014-12-04

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension. This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Centre Hospitalier Universitaire de Québec, CHU de Québec
CHU de Quebec-Universite Laval

Treatments:

Latanoprost

Criteria

Inclusion Criteria:

1. >18 years old

2. Primary open angle glaucoma, glaucoma suspect or ocular hypertension

3. Bilateral

4. Without any treatment or treated with latanoprost or another prostaglandin analog

5. Intraocular pressure >21mmHg (without treatment or after a washout period)

Exclusion Criteria:

1. Intraocular pressure >30mmHg

2. Secondary glaucoma (uveitic, neovascular, traumatic ) or congenital glaucoma

3. Pseudoexfoliation syndrome

4. Pigmentary dispersion syndrome or Pigmentary glaucoma

5. Severe glaucoma; Cup-to-disc ratio ≥9/10 OU Loss of central visual field (central 10°)

6. Use of other topical medication to lower intraocular pressure

7. Pregnancy and breast-feeding

8. Being allergic to latanoprost or benzalkonium chloride (BAK)

9. Current use of acetazolamide (Diamox)

10. Changes of systemic doses of beta-blockers during study

11. Recent use of topical corticosteroids (<1 month)

12. Contact lens wearer

13. Closed angle at gonioscopy or past angle closure glaucoma

14. Filtration surgery (example. : trabeculectomy)

15. Selective Laser Trabeculoplasty (SLT) or Argon Laser Trabeculoplasty(ALT)

16. Recent Intraocular surgery (<3 months)

17. Refractive surgery

18. Recent iridotomy or capsulotomy (<3 months)

19. Past medical history of ocular trauma (example : angle recession)

20. Past or active uveitis

21. Herpetic keratitis

22. Monocular vision