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

Phase I Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Compared to Lagricel® Ofteno Single Dose on the Ocular Surface of Clinically Healthy Subjects

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

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.