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

Safety Clinical Trial

— PRO-172  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693429
• Other study ID #: SOPH172-0919/I
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2020
• Est. completion date: December 8, 2020

Study information

• Verified date: December 2021
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 8, 2020
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Comfort
• Ocular Surface
• Safety
• Tolerability

Intervention

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

Locations

Country	Name	City	State
Mexico	Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of related non expected adverse events	Presence/absence of related non expected adverse events	Day 10
Primary	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	Changes in Best Corrected Visual Acuity (BCVA)	Evaluation of best corrected visual acuity compared to baseline value	Day 8
Secondary	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
Secondary	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
Secondary	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
Secondary	Chemosis incidence	Chemosis incidence	Day 8