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

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.

Study Overview

• Status: Terminated
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Intervention / Treatment: Drug: Generic latanoprost; Drug: Brand-name latanoprost

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1S 4L8
    • Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Generic latanoprost; 1 eye drop hs	Drug: Generic latanoprost; Drug: Brand-name latanoprost; Other Names: Xalatan
ACTIVE_COMPARATOR: Brand-name latanoprost; 1 eye drop hs	Drug: Generic latanoprost; Drug: Brand-name latanoprost; Other Names: Xalatan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intraocular Pressure (IOP)	Goldman applanation tonometry will be used to measure IOP.	8 weeks, 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Marie-Josée Fredette, MD, FRCSC, Centre de recherche du CHU de Québec; Université Laval

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): December 4, 2014
• Study Completion (ACTUAL): December 4, 2014

Study Registration Dates

• First Submitted: January 19, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (ESTIMATE): January 28, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 23, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Ocular hypertension; intraocular pressure; generic; Primary open angle glaucoma; latanoprost
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: C13-11-1242