Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel

• Status: Active, not recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects.

Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects.

Phase I clinical study, controlled, of parallel groups, double blind, randomized, exploratory Therapeutic indication of PRO-165: Eye lubricant

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• Signed informed consent.

• Systemically and ophthalmologically healthy subjects evaluated during the clinical history.

• Age between 18 to 45 years.

• Both genders.

• Blood tests (complete blood count, three element blood chemistry and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%)

• Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute)

• Visual capacity 20/30 or better, in both eyes.

• Intraocular pressure ≥11 and ≤ 21 mmHg.

Exclusion Criteria:

• Subjects with a history of hypersensitivity to any of the components of the research products.

• Subject users of topical ophthalmic medications of any pharmacological group.

• Subject users of medication by any other route of administration.

• Women who are pregnant or lactating.

• Women without a history of bilateral tubal obstruction, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.

• Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.

• Known diagnosis of liver disease

• Inability to attend or answer the evaluations made in each of the visits.

• Positive tobacco use (specified as cigarette consumption regardless of quantity and frequency)

• Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).

• Contact lens users.

Medical and therapeutic exclusion criteria.

• History of any chronic-degenerative disease.

• Inflammatory or infectious disease, active at the time of study entry.

• Injuries or traumatisms not resolved at the time of entry into the study.