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

Laboratorios Sophia

Status and phase

Completed

Phase 1

Conditions

Ocular Surface

Ocular Comfort

Tolerability

Safety

Treatments

Drug: Bepotastine Besilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT04693429

SOPH172-0919/I

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.