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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Safety, Tolerability, Ocular Surface, Ocular Comfort

Intervention / Treatment
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* Drug: Bepotastine Besilate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Controlled, single center, non comparative
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |