Comparison of Efficacy & Tolerability Between Ganfort vs Krytantek in Mexican Patients With Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this phase IV clinical multi-center trial will be to compare the efficacy and safety of Ganforti® versus Krytantek®, using a cross-over design during a six month period (including a one-month wash-in period) in POAG and OH patients.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan S.A. DE C.V..
• Treatments: Cloprostenol; Timolol

Criteria

Inclusion Criteria:

• Best-corrected visual acuity of at least 20/80 in both eyes

• Age above 17 years

• Use of active contraceptive methods for women in their reproductive phase of life

• Complete demographic and baseline information (Eligibility Visit)

• IOP ≥ 18 mm Hg and ≤ 36 mm Hg

• Significant visual field loss in the previous year

• Uncontrolled systemic disease

• Active ocular disease or intraocular surgery within past three months

• Use of other medications with possible substantial effect on IOP

• Allergy/contraindication to any of the study components

• Severe glaucoma according to Hodapp's criteria

• Incapacity or unwillingness to participate in the study

Exclusion Criteria:

-Any ocular illness other than mild-moderate lens loss of transparency and glaucoma/ocular hypertension