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

NCT01737853 | Completed

• 1 other identifier: ALLE-GANFORT-001-4-2011
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Primary Open-Angle Glaucoma; Ocular Hypertension; Ganfort

Outcome Measures

Primary Outcomes (1)

• IOP (Intraocular Pressure)

  6 months

Secondary Outcomes (1)

• Adverse Events

  6 months

Study Arms (2)

Ganfort's Group

Ganfort® QD for patients under Krytantek® For patients assigned to the Ganfort's group, instructions for applying one drop QD (8:00 PM ± 30 minutes)

Drug: Ganforti

Krytantek's Group

Krytantek® BID for patients under Ganforti® For patients assigned to the Krytantek's group, application schedule will be BID (8:00 AM ± 30 minutes and 8:00 PM ± 30 minutes)

Drug: Krytantek

Interventions

Ganforti DRUG

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)

Also known as: Ganfort

Ganfort's Group

Krytantek DRUG

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)

Krytantek's Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll 90 patients (45 per treatment group) to yield approximately 80 evaluable patients (40 per treatment group. Sample size calculation will take into account the following assumptions: * standardized effect size of 0.60 * 2-sided α value of 0.01 and a β value of 0.10

You may qualify if:

• 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

You may not qualify if:

• Any ocular illness other than mild-moderate lens loss of transparency and glaucoma/ocular hypertension

Sponsors & Collaborators

• Allergan S.A. DE C.V..: lead

Study Sites (4)

Global Galucoma Institute

Guadalajara, Jalisco, Mexico

Location

Asociación Para Evitar La Ceguera en México

Mexico City, Mexico City, Mexico

Location

Hospital de Nuestra Señora de la Luz

Mexico City, Mexico City, Mexico

Location

Instituto Oftalmológico Conde de Valencian

Mexico City, Mexico City, Mexico

Location

Related Publications (1)

• Garcia-Lopez A, Paczka JA, Jimenez-Roman J, Hartleben C. Efficacy and tolerability of fixed-combination bimatoprost/timolol versus fixed-combination dorzolamide/brimonidine/timolol in patients with primary open-angle glaucoma or ocular hypertension: a multicenter, prospective, crossover study. BMC Ophthalmol. 2014 Dec 19;14:161. doi: 10.1186/1471-2415-14-161.

  PMID: 25527295 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Ganfort

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Jose A Paczka, MD

  director of Global Glaucoma Institute; Guadalajara, Jalisco, México.

  PRINCIPAL INVESTIGATOR

• Karen Ortiz

  Allergan SA de CV

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: November 30, 2012
• Study Start: February 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2012
• Last Updated: November 30, 2012

Record last verified: 2012-11

Locations

ME (4)