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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02047630
• Other study ID #: C13-11-1242
• Status: Terminated
• Phase: Phase 4
• First received: January 19, 2014
• Last updated: July 23, 2017
• Start date: January 2014
• Est. completion date: December 4, 2014

Study information

• Verified date: July 2017
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: December 4, 2014
• Est. primary completion date: December 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• Generic latanoprost

• Brand-name latanoprost

Locations

Country	Name	City	State
Canada	Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec	Québec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular Pressure (IOP)	Goldman applanation tonometry will be used to measure IOP.	8 weeks, 16 weeks
Secondary	Change in Conjunctival hyperemia		8 weeks, 16 weeks
Secondary	Change in corneal staining	Oxford grading scale	8 weeks, 16 weeks
Secondary	Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)		8 weeks, 16 weeks