Glaucoma Primary Open Angle Clinical Trial
Official title:
Comparison of Efficacy and Tolerability Between 2fixed Combinations for Treating Mexican Patients With Primary Open-Angle Glaucoma or Ocular Hypertension: Ganforti vs Krytantek.A Phase IV,Examiner-masked Cross-over Multicenter Clinical Trial
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | June 2012 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Case-Crossover, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Mexico | Global Galucoma Institute | Guadalajara | Jalisco |
Mexico | Asociación Para Evitar La Ceguera en México | Mexico City | DF |
Mexico | Hospital de Nuestra Señora de la Luz | Mexico City | |
Mexico | Instituto Oftalmológico Conde de Valencian | Mexico City | DF |
Lead Sponsor | Collaborator |
---|---|
Allergan S.A. DE C.V.. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IOP (Intraocular Pressure) | 6 months | No | |
Secondary | Adverse Events | 6 months | Yes |