Phase 1
N=22
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
Safety · Tolerability · Ocular Surface · Ocular Comfort
Bottom Line
View on ClinicalTrials.gov: NCT04693429 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Incidence of Related Unexpected Adverse Events (AE) — 12 Number of unexpected related AE
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Bepotastine Besilate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Related Unexpected Adverse Events (AE) |
12 | — |
| PRIMARY Ocular Comfort Index |
17.70 | — |
| SECONDARY Changes in Best Corrected Visual Acuity (BCVA) |
0.921 | — |
| SECONDARY Conjunctival and Corneal Staining With Lissamine Green |
60.5; 39.5 | — |
| SECONDARY Conjunctival and Corneal Staining With Fluorescein |
81.6; 13.2; 5.3 | — |
| SECONDARY Conjunctival Hyperemia |
60.5; 39.5 | — |
| SECONDARY Chemosis Incidence |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04693429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.