Clinical trial NCT02047630: Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Primary open angle glaucoma
Ocular hypertension
latanoprost
generic
intraocular pressure
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Intraocular Pressure (IOP)
timeFrame: 8 weeks, 16 weeks
Secondary outcomes:
measure: Change in Conjunctival hyperemia
timeFrame: 8 weeks, 16 weeks
measure: Change in corneal staining
timeFrame: 8 weeks, 16 weeks
measure: Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)
timeFrame: 8 weeks, 16 weeks
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Study officials:
affiliation: Centre de recherche du CHU de Québec; Université Laval
name: Marie-Josée Fredette, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: