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

NCT ID: NCT04693429

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2020-12-08

Brief 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.

Conditions

Safety; Tolerability; Ocular Surface; Ocular Comfort

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PRO-172

PRO-172 Ophthalmic Solution QID (four times per day). Single arm.

Group Type: EXPERIMENTAL

Bepotastine Besilate

Intervention Type: DRUG

Bepotastine Besilate 1.5% QID (quater in die) for 7 days

Interventions

Bepotastine Besilate

Bepotastine Besilate 1.5% QID (quater in die) for 7 days

Intervention Type: DRUG

Other Intervention Names

PRO-172

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

Guadalajara, Jalisco, Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SOPH172-0919/I

Identifier Type: -

Identifier Source: org_study_id