This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.
This is a Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. The variables to be evaluated include: Primary (safety): * Incidence of unexpected adverse events related to the interventions * Incidence of conjunctival hyperemia and chemosis * Changes in Best Corrected Visual Acuity (BCVA) assessed with Snellen chart * Changes in ocular surface integrity using fluorescein staining, using the standard Oxford scale. Primary (tolerability): \- Changes in the ocular comfort index (OCI) score Secondary (safety): \- Incidence of unexpected adverse events related to the interventions(excluding conjunctival hyperemia and/or chemosis). Secondary (tolerability): \- Presence of other ocular symptoms (burning, foreign body sensation, pruritus and lacrimation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
IIMET Investigación e Innovación en Medicina Traslacional
Guadalajara, Jalisco, Mexico
Incidence of Unexpected Adverse Events Related to the Interventions
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention. Adverse events where inquired and evaluated in every time point specified in the time frame, however, the final number of adverse events reported throught the entire study was evaluated for each group.
Time frame: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
Incidence of Conjunctival Hyperemia
Any signs of conjunctival hyperemia in between interventions.
Time frame: Days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit)
Changes in Best Corrected Visual Acuity (BCVA)
The BCVA will be evaluated through Snellen chart.
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
Number of patients with any changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale compared to baseline. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E.
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Changes in the Ocular Comfort Index (OCI) Score Between Interventions.
The Ocular Comfort Index is a questionnaire designed to measure ocular surface irritation. It assesses symptoms related to comfort in cases of ocular surface disorders. The Ocular Comfort Index is composed of 12 items that assess the frequency and intensity symptoms. Each item is scored on a scale from 0 to 6 (never to always, or absent to severe). The total score becomes a linear continuous interval scale, which ranges from 0 (least symptomatic) to 100 (most symptomatic). The questionnaire was administered to each research subject, allowing them to respond calmly without any pressure and/or coercion. The results were collected using the Ocular Comfort Index calculator \[1\], obtaining a logit score and a 0-100 scale score for each subject. \[1\].- M. E. Johnson, "Measurement of Ocular Surface Irritation on a Linear Interval Scale with the Ocular Comfort Index," Investigative Ophthalmology \& Visual Science, vol. 48, nº 10, 2007.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Days 0 (Basal Visit), and 8 (Final Visit)
Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention, excluding conjunctival hyperemia and chemosis. Unexpected adverse events where inquired and evaluated in every time point specified in the time frame, however, the final number of adverse events reported throught the entire study was evaluated for each group.
Time frame: Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
To Assess the Tolerability of PRO-231 Ophthalmic Solution
To assess the tolerability of PRO-231 ophthalmic solution applied to the ocular surface, in healthy volunteers, versus VIGAMOXI®, by means of: Presence of ocular symptoms (burning, foreign body sensation, pruritus and lacrimation) between interventions.
Time frame: Days 3 (Visit 1), 8 (Final Visit)