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

Phase 4

Terminated

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Generic latanoprost; Drug: Brand-name latanoprost

• Registration Number: NCT02047630
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-19
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-28
• Primary Completion: 2014-12-04
• Study Completion: 2014-12-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-23
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Brand-name latanoprost	Brand-name latanoprost	1 eye drop hs
Brand-name latanoprost	Generic latanoprost	1 eye drop hs
Generic latanoprost	Generic latanoprost	1 eye drop hs
Generic latanoprost	Brand-name latanoprost	1 eye drop hs

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP)	8 weeks, 16 weeks	Goldman applanation tonometry will be used to measure IOP.

Secondary Outcome Measures

Name	Time	Method
Change in corneal staining	8 weeks, 16 weeks	Oxford grading scale
Change in Conjunctival hyperemia	8 weeks, 16 weeks
Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)	8 weeks, 16 weeks

Trial Locations

Locations (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec; 🇨🇦 Québec, Canada