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.
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).
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Observational Model: Case-Crossover, Time Perspective: Prospective