Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+

Laboratorios Sophia S.A de C.V.22 enrolled

Overview

Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Safety Tolerability Ocular Surface Ocular Comfort

Interventions

Bepotastine BesilateDRUG

Bepotastine Besilate 1.5% QID (quater in die) for 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically healthy volunteers * Being capable of voluntarily grant a signed informed consent. * Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures. * Being between 18 and 45 years old. * Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method of intrauterine device (IUD) during the study. * Having a best corrected visual acuity equal or better than 20/30 in both eyes. * Showing normal vital signs. * Having an intraocular pressure between 10 and 21 mmHg. Exclusion Criteria: * Using any kind of ophthalmic topical product. * Using drugs or herbal products, through any administration route. * For women: pregnancy, breastfeeding or planning to become pregnant during the time of the study. * Having participated in clinical trials 90 days prior to inclusion in this study. * Having participated previously in this study. * Using contact lenses and not being able to suspend such use during the period of the study. * Being unable to follow the lifestyle modification considerations required for the study. * Having started the use of hormonal contraceptives of IUD within 30 days previous of inclusion in this study. * Suffering any chronic degenerative diseases. * Suffering active inflammatory of infectious disease when entering this study. * Suffering unresolved lesions or traumas when entering this study. * Having a previous history of any kind of ocular surgery. * Having a previous history of any surgical procedure, non ophthalmological, within the last 3 months.

Locations (1)

Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

Incidence of Related Unexpected Adverse Events (AE)

Presence/absence of related non expected adverse events

Time frame: Day 10

Ocular Comfort Index

Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.

Time frame: Day 8

Secondary Outcomes

Changes in Best Corrected Visual Acuity (BCVA)

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: Baseline vs Day 8

Conjunctival and Corneal Staining With Lissamine Green

Conjunctival and corneal staining with lissamine green. 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).

Time frame: Day 8

Conjunctival and Corneal Staining With Fluorescein

Conjunctival and corneal staining with fluorescein. The evaluation will take place after applying the fluorescein tain 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).

Data from ClinicalTrials.gov

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