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

Sponsor

Laboratorios Sophia S.A de C.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT04693429

Collaborator

(none)

Enrollment

Location

Arm

2.5

Actual Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Safety Tolerability Ocular Surface Ocular Comfort	Drug: Bepotastine Besilate	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Controlled, single center, non comparativeControlled, single center, non comparative

Masking:

None (Open Label)

Primary Purpose:

Other

Official 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

Actual Study Start Date :

Sep 24, 2020

Actual Primary Completion Date :

Nov 27, 2020

Actual Study Completion Date :

Dec 8, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of related non expected adverse events [Day 10]
Presence/absence of related non expected adverse events
Ocular Comfort Index [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.	Guadalajara	Jalisco	Mexico	44190

Sponsors and Collaborators

Laboratorios Sophia S.A de C.V.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laboratorios Sophia S.A de C.V.

ClinicalTrials.gov Identifier:

NCT04693429

Other Study ID Numbers:

SOPH172-0919/I

First Posted:

Jan 5, 2021

Last Update Posted:

Jan 11, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bepotastine besilate

Study Results

No Results Posted as of Jan 11, 2022