Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution

Laboratorios Sophia S.A de C.V.34 enrolled

Overview

Study design: Phase I clinical trial, single-center, controlled, parallel group, open, randomized. Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes). Estimated duration of the study: 5 months Therapeutic indication: Eye lubricant Use: Dry Eye Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured by Laboratorios Sophia on the ocular surface of clinically healthy subjects. Hypothesis: H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile similar to Lagricel® Ofteno single dose in healthy subjects. H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability profile than Lagricel® Ofteno single dose in healthy subjects. Main inclusion criteria: Clinically healthy subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye

Interventions

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * To be clinically healthy * To have the ability to voluntarily grant your signed informed consent * To have the willingness to comply with scheduled visits treatment plan and other study procedures * Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period. * To have a better corrected visual acuity of 20/30 or better in both eyes. * To have vital signs in normal parameters. * To have an intraocular pressure between ≥10 and ≤ 21 mmHg. Exclusion Criteria: * To be user of ophthalmic topical products of any kind. * To be user of medicines, or herbal products, by any other route of administration. * In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period. * Having participated in clinical research studies 90 days prior to inclusion in this study. * Having previously participated in this same study. * To be a user of contact lenses and can not suspend their use during the study. * Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study. * To have a history of any chronic degenerative disease. * Having inflammatory or infectious disease, active at the time of admission to the study. * Having injuries or unresolved injuries at the time of admission to the study. * Having a history of any type of eye surgery. * Having undergone surgical procedures, not ophthalmological, in the last 3 months. * To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.

Outcomes

Primary Outcomes

Presence of Adverse Events (AEs)

the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent

Time frame: during the 10 days of evaluation, including the safety call (day 11).

Eye Comfort Index (ECI)

It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).