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

Study Overview
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Brief Summary
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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.

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Generic latanoprost
* Drug: Brand-name latanoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old Primary open angle glaucoma, glaucoma suspect or ocular hypertension Bilateral Without any treatment or treated with latanoprost or another prostaglandin analog Intraocular pressure >21mmHg (without treatment or after a washout period) Exclusion Criteria: Intraocular pressure >30mmHg Secondary glaucoma (uveitic, neovascular, traumatic ) or congenital glaucoma Pseudoexfoliation syndrome Pigmentary dispersion syndrome or Pigmentary glaucoma Severe glaucoma; Cup-to-disc ratio ≥9/10 OU Loss of central visual field (central 10°) Use of other topical medication to lower intraocular pressure Pregnancy and breast-feeding Being allergic to latanoprost or benzalkonium chloride (BAK) Current use of acetazolamide (Diamox) Changes of systemic doses of beta-blockers during study Recent use of topical corticosteroids (<1 month) Contact lens wearer Closed angle at gonioscopy or past angle closure glaucoma Filtration surgery (example. : trabeculectomy) Selective Laser Trabeculoplasty (SLT) or Argon Laser Trabeculoplasty(ALT) Recent Intraocular surgery (<3 months) Refractive surgery Recent iridotomy or capsulotomy (<3 months) Past medical history of ocular trauma (example : angle recession) Past or active uveitis Herpetic keratitis Monocular vision

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Generic latanoprost<br>1 eye drop hs | Drug: Generic latanoprost<br> <br> Drug: Brand-name latanoprost<br> <br> * Other names: Xalatan;|
| Active Comparator: Brand-name latanoprost<br>1 eye drop hs | Drug: Generic latanoprost<br> <br> Drug: Brand-name latanoprost<br> <br> * Other names: Xalatan;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary open angle glaucoma, Ocular hypertension, latanoprost, generic, intraocular pressure