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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan S.A. DE C.V..
ClinicalTrials.gov Identifier:
NCT01737853
First received: October 9, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Glaucoma Primary Open Angle
Drug: Ganforti
Drug: Krytantek

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Allergan S.A. DE C.V..:

Primary Outcome Measures:
  • IOP (Intraocular Pressure) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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)
Other Name: 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737853

Locations
Mexico
Instituto Oftalmológico Conde de Valencian
Mexico City, DF, Mexico
Asociación Para Evitar La Ceguera en México
Mexico City, DF, Mexico
Global Galucoma Institute
Guadalajara, Jalisco, Mexico
Hospital de Nuestra Señora de la Luz
Mexico City, Mexico
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Allergan S.A. DE C.V..
ClinicalTrials.gov Identifier: NCT01737853     History of Changes
Other Study ID Numbers: ALLE-GANFORT-001-4-2011
Study First Received: October 9, 2012
Last Updated: November 29, 2012
Health Authority: Mexico: Federal Commission for Protection Against Health Risks
Mexico: Secretaria de Salud

Keywords provided by Allergan S.A. DE C.V..:
Primary Open-Angle Glaucoma
Ocular Hypertension
Ganfort

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2014