Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension
NCT ID: NCT02047630
Last Updated: 2017-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
60 participants
INTERVENTIONAL
2014-01-31
2014-12-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Generic latanoprost
1 eye drop hs
Generic latanoprost
Brand-name latanoprost
Brand-name latanoprost
1 eye drop hs
Generic latanoprost
Brand-name latanoprost
Interventions
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Generic latanoprost
Brand-name latanoprost
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Marie-Josée Fredette
MD, FRCSC
Principal Investigators
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Marie-Josée Fredette, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Centre de recherche du CHU de Québec; Université Laval
Locations
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Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, , Canada
Countries
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Other Identifiers
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C13-11-1242
Identifier Type: -
Identifier Source: org_study_id
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