Status:
COMPLETED
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Lead Sponsor:
Laboratorios Sophia S.A de C.V.
Conditions:
Dry Eye
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Study design: Phase I clinical trial, single-center, controlled, parallel group, open, randomized. Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes). Estimat...
Eligibility Criteria
Inclusion
- To be clinically healthy
- To have the ability to voluntarily grant your signed informed consent
- To have the willingness to comply with scheduled visits treatment plan and other study procedures
- Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period.
- To have a better corrected visual acuity of 20/30 or better in both eyes.
- To have vital signs in normal parameters.
- To have an intraocular pressure between ≥10 and ≤ 21 mmHg.
Exclusion
- To be user of ophthalmic topical products of any kind.
- To be user of medicines, or herbal products, by any other route of administration.
- In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period.
- Having participated in clinical research studies 90 days prior to inclusion in this study.
- Having previously participated in this same study.
- To be a user of contact lenses and can not suspend their use during the study.
- Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study.
- To have a history of any chronic degenerative disease.
- Having inflammatory or infectious disease, active at the time of admission to the study.
- Having injuries or unresolved injuries at the time of admission to the study.
- Having a history of any type of eye surgery.
- Having undergone surgical procedures, not ophthalmological, in the last 3 months.
- To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04081610
Start Date
September 9 2019
End Date
November 13 2019
Last Update
May 3 2021
Active Locations (1)
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1
Biomedical research G & LS de RL de CV
Guadalajara, Jalisco, Mexico, 45070