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

Study Identifier
ALLE-GANFORT-001-4-2011
CT.gov Identifier
NCT01737853
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Glaucoma - Open Angle
    • Study Drug
  • Ganforti
  • Krytantek
    • Phase
    N/A
    Sex
    Female & Male
    Age
    N/A
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Global Galucoma Institute
    Guadalajara, Jalisco, Mexico
    Status
    Not applicable
    Location
    Asociación Para Evitar La Ceguera en México
    Mexico City, Mexico City, Mexico
    Status
    Not applicable
    Location
    Hospital de Nuestra Señora de la Luz
    Mexico City, Mexico City, Mexico
    Status
    Not applicable
    Location
    Instituto Oftalmológico Conde de Valencian
    Mexico City, Mexico City, Mexico
    Status
    Not applicable