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

NCT04693429 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH172-0919/I
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Related Unexpected Adverse Events (AE)

  Presence/absence of related non expected adverse events

  Day 10

• Ocular Comfort Index

  Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.

  Day 8

Secondary Outcomes (5)

• Changes in Best Corrected Visual Acuity (BCVA)

  Baseline vs Day 8

• Conjunctival and Corneal Staining With Lissamine Green

  Day 8

• Conjunctival and Corneal Staining With Fluorescein

  Day 8

• Conjunctival Hyperemia

  Day 8

• Chemosis Incidence

  Day 8

Study Arms (1)

PRO-172

EXPERIMENTAL

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

Drug: Bepotastine Besilate

Interventions

Bepotastine Besilate DRUG

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

Also known as: PRO-172

PRO-172

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44190, Mexico

Location

MeSH Terms

Interventions

bepotastine besilate

Results Point of Contact

• Title: Alejandra Sanchez-Ríos M.D.
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

:+52 (33) 3001 4200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Controlled, single center, non comparative

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 5, 2021
• Study Start: September 24, 2020
• Primary Completion: November 27, 2020
• Study Completion: December 8, 2020
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)