Status:
COMPLETED
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
Lead Sponsor:
Laboratorios Sophia S.A de C.V.
Conditions:
Safety
Tolerability
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04693429
Start Date
September 24 2020
End Date
December 8 2020
Last Update
July 16 2025
Active Locations (1)
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1
Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
Guadalajara, Jalisco, Mexico, 44190