Overview

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