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

• Status: Completed
• Trial end date: 2020-12-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Bepotastine besilate

Criteria

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.