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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737853
• Other study ID #: ALLE-GANFORT-001-4-2011
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: November 29, 2012
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2012
• Source: Allergan S.A. DE C.V..
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health RisksMexico: Secretaria de Salud
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Primary Open Angle
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

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)
• 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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan S.A. DE C.V..

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP (Intraocular Pressure)		6 months	No
Secondary	Adverse Events		6 months	Yes