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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01737853 on ClinicalTrials.gov