Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Keywords
Primary open angle glaucoma, Ocular hypertension, latanoprost, generic, intraocular pressure
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.
Interventions
DRUGGeneric latanoprost
DRUGBrand-name latanoprost
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) | 8 weeks, 16 weeks | Goldman applanation tonometry will be used to measure IOP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Conjunctival hyperemia | 8 weeks, 16 weeks | — |
| Change in corneal staining | 8 weeks, 16 weeks | Oxford grading scale |
| Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure) | 8 weeks, 16 weeks | — |
Countries
Canada
Outcome results
None listed