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Completed

NCT Number: NCT04693429

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

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.

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Key information

Conditions

Safety Ocular Comfort Ocular Surface Tolerability

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Guadalajara, Jalisco, 44190, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bepotastine Besilate

Drug

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

Other names: PRO-172

Primary outcomes

  1. Incidence of Related Unexpected Adverse Events (AE)

    Time frame: Day 10

    Presence/absence of related non expected adverse events

  2. Ocular Comfort Index

    Time frame: Day 8

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

Secondary outcomes

  1. Changes in Best Corrected Visual Acuity (BCVA)

    Time frame: Baseline vs Day 8

    Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.

  2. Conjunctival and Corneal Staining With Lissamine Green

    Time frame: Day 8

    Conjunctival and corneal staining with lissamine green. The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).

  3. Conjunctival and Corneal Staining With Fluorescein

    Time frame: Day 8

    Conjunctival and corneal staining with fluorescein. The evaluation will take place after applying the fluorescein tain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).

  4. Conjunctival Hyperemia

    Time frame: Day 8

    Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4).

  5. Chemosis Incidence

    Time frame: Day 8

    Chemosis incidence will be evaluated at the end of the treatment at the final visit

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of Healthy Volunteers

Acronym: PRO-172

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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