Comparison of Efficacy & Tolerability Between Ganfort vs Krytantek in Mexican Patients With Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
NCT01737853 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90
Last updated 2012-11-30
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.
Conditions
- Glaucoma Primary Open Angle
Interventions
- DRUG
-
Ganforti
Enrolled patients will be visiting their clinical site at month 2 and month 3, after starting the study medication; at the end of the third month of treatment, a cross-over maneuver will be indicated; all patients will undergo a follow-up scheme similar to the first period of the study (at month 5 and month 6)
- DRUG
-
Krytantek
Enrolled patients will be visiting their clinical site at month 2 and month 3, after starting the study medication; at the end of the third month of treatment, a cross-over maneuver will be indicated; all patients will undergo a follow-up scheme similar to the first period of the study (at month 5 and month 6)
Sponsors & Collaborators
-
Allergan S.A. DE C.V..
lead INDUSTRY
Principal Investigators
-
Jose A Paczka, MD · director of Global Glaucoma Institute; Guadalajara, Jalisco, México.
-
Karen Ortiz · Allergan SA de CV
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2011-02-28
- Completion
- 2012-06-30
Countries
- Mexico
Study Locations
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