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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma Primary Open Angle
• Intervention / Treatment: Drug: Ganforti; Drug: Krytantek

Detailed Description

A prospective examiner-masked, cross-over competitive multicenter clinical trial of 90 consecutive patients derived from three centers in Mexico will be carried out. All eligible eyes should have a diagnosis of either ocular hypertension or mild to moderate POAG with at least 21 mm Hg at baseline (Eligibility Visit), under treatment with either Ganforti® QD or Krytantek® BID. Patients identified to have the selection criteria at the Screening Visit will be scheduled for an Eligibility Visit prior to be prescribed with either of the two study medications (Ganforti® QD for patients under Krytantek®, and Krytantek® BID for patients under 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). A battery of tests will be applied in a pre-established regime (table 1). Visual acuity, refraction, biomicroscopy, gonioscopy, dilated fundus examination, Humphrey 24-2 visual field (SITA-Standard), ocular surface fluorescein staining, tear breakup time, OSDI© (Ocular Surface Index) and central ultrasound pachymetry will be administered at baseline and month 6 (at the conclusion of the study). IOP from applanation Goldmann tonometry (8:00 AM ± 1 hour and 10:00 AM ± 1 hour), blood pressure, pulse and a comprehensive ophthalmological examination will be performed at each visit.

Candidate patients will have an initial screening visit where entry criteria must be met (see section 1.7.). Study medication will remain masked to the examiner during the entire trial. For patients assigned to the Ganforti's group, instructions for applying one drop QD (8:00 PM ± 30 minutes); for patients assigned to the Krytantek's group, application schedule will be BID (8:00 AM ± 30 minutes and 8:00 PM ± 30 minutes). Bottles will be given to the patient in a closed labeled box (with the randomization number on it), dispensed by the office assistant, and have to be returned in the same box to the assigned office personnel but never to the principal investigator or sub-investigator, in order to preserve the single-masked nature of the study. New study medication bottles will be dispensed at baseline visit, and monthly after such visit.

Patients will receive verbal instructions, written reminders and periodic phone calls in order to adhere to medication application, as well to scheduled visits (table 1). Outcome variables will also include adverse events (serious, and non-serious, according to the principal investigator's clinical opinion) derived from all examination items. Patient´s and treating ophthalmologist´s subjective satisfaction to the study medication performance will also will be assessed through the closed-end questions (CRF form).

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Hospital de Nuestra Señora de la Luz
  • DF
    • Mexico City, DF, Mexico
      • Asociación Para Evitar la Ceguera en México
    • Mexico City, DF, Mexico
      • Instituto Oftalmológico Conde de Valencian
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Global Galucoma Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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); Other Names: Ganfort
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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IOP (Intraocular Pressure)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	6 months

Collaborators and Investigators

• Sponsor: Allergan S.A. DE C.V..
• Investigators: Principal Investigator: Jose A Paczka, MD, director of Global Glaucoma Institute; Guadalajara, Jalisco, México.; Study Director: Karen Ortiz, Allergan SA de CV

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (ESTIMATE): November 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Primary Open-Angle Glaucoma; Ganfort
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: ALLE-GANFORT-001-4-2011