Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle glaucoma or ocular hypertension during 90 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Krytantek Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days.
Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Eliptic Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days.
Servicios Médicos y de Investigación Clínica InspirePharma S. de R.L.de C.V.
Monterrey, Mexico
Change in intraocular Pressure (IOP)
Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated at 9:00 and at 11:00 hrs. (± 30 minutes). Both measurements and their average will be registered. Normal values are considered between 10 and 21 mmHg.
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Change in Best Corrected Visual Acuity (BCVA)
With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc.
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Changes in optic nerve cup/disc ratio
Both clinical and imaging evaluation will be performed. For clinical evaluation, after the application of a topical ophthalmic mydriatic (tropicamide 0.8% / phenylephrine 5%), indirect ophthalmoscopy will be performed through the aid of a fundus lens in a slit lamp. For imaging, optic coherence tomography (OCT) will be used.
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)
Change in nerve fibers and ganglion cell thickness
Spectral domain OCT is a non invasive tool that will be used to evaluate quantitatively the thickness of retinal nerve fibers and ganglion cell layers.
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in optic nerve image
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Through a fundus camera a photograph will be taken to obtain a faithful record of any possible changes to the optic nerve head characteristics.
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)
Change in central corneal thickness
Measured through ultrasonic pachymetry, three assessments will be performed, these and its average will be recorded.
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in visual fields
Visual fields will be evaluated with a SITA standard automated white-on-white perimetry performed with a Humphrey perimeter. To be considered reliable, fixation losses, false positives and false negatives must be under 20%. Mean deviation (MD) and pattern standard deviation (PSD) will be recorded.
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in ocular surface integrity (conjunctival hyperemia, chemosis, and corneal fluorescein staining)
By means of a slit lamp, conjunctival hyperemia, chemosis, and corneal fluorescein staining will be evaluated. Conjunctival hyperemia will be graded according to Efron's scale (5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4)). Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent. Fluorescein staining evaluation will take place after applying the fluorescein stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Incidence of adverse events
Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution.
Time frame: Day: 75 (± 3) (safety call)
Changes in Ocular Comfort Index
Ocular Comfort Index (OCI) Questionnaire will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)