Phase IV, non inferiority, controlled, open, multicenter clinical study to compare the efficacy of the Ophthalmic Solution Humylub Ofteno® PF against Hyabak® and Lagricel Ofteno® PF applied quater in die (QID) for 30 days in patients with mild to moderate dry eye disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
182
Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
Guadalajara, Jalisco, Mexico
Change in Ocular Surface Disease Index (OSDI)
OSDI is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). A higher score is a worse outcome. • This outcome measure considered the Per Protocol (PP) population.
Time frame: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Noninvasive Keratograph Break-up Time (NIKBUT)
This evaluation will be performed through an Oculus Keratograph 5M, and the parameter "first break-up time" will be recorded as NIKBUT. A lower value is a worse outcome. This outcome measure considered the Per Protocol (PP) population.
Time frame: Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change of Conjunctival and Corneal Staining With Lissamine Green
The change in proportion of participant's abscence of conjunctival and corneal staining with lissamine green will be analyzed. The evaluation will take place after applying the lissamine green 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). This outcome measure considered the Per Protocol (PP) population.
Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change of Conjunctival and Corneal Staining With Fluorescein
The change in proportion of participant's abscence of conjunctival and corneal staining with fluorescein will be analyzed. The 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). This outcome measure considered the Per Protocol (PP) population.
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Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change in Conjunctival Hyperemia
The change in proportion of participant's score will be analyzed. Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4). This outcome measure considered the Per Protocol (PP) population.
Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Incidence of Related Non Expected Adverse Events
Number of related non expected adverse events observed per group. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
Time frame: Days: 0 (eligibility visit), 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), 31 - 33 (± 1) (final visit), and 38 - 40 (± 1) (safety call).
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 (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. Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20. This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.
Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change in Incidence of Chemosis
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 per subject. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).