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

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

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.

Study Overview

• Status: Completed
• Conditions: Tolerability; Safety; Ocular Surface; Ocular Comfort
• Intervention / Treatment: Drug: Bepotastine Besilate

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44190
      • Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRO-172; PRO-172 Ophthalmic Solution QID (four times per day). Single arm.	Drug: Bepotastine Besilate; Bepotastine Besilate 1.5% QID (quater in die) for 7 days; Other Names: PRO-172

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of related non expected adverse events	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Best Corrected Visual Acuity (BCVA)	Evaluation of best corrected visual acuity compared to baseline value	Day 8
Conjunctival and corneal staining with lissamine green	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).	Day 8
Conjunctival and corneal staining with fluorescein	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).	Day 8
Conjunctival hyperemia	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).	Day 8
Chemosis incidence	Chemosis incidence	Day 8

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): November 27, 2020
• Study Completion (Actual): December 8, 2020

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Allergic Agents; Bepotastine besilate
• Other Study ID Numbers: SOPH172-0919/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No