Clinical trial NCT04081610: Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Compared to Lagricel® Ofteno Single Dose on the Ocular Surface of Clinically Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye
Keywords: Dry eye
eye lubricant
sodium hyaluronate
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, controlled, parallel group, open, randomized
Primary purpose: TREATMENT

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).

Estimated duration of the study: 5 months

Therapeutic indication: Eye lubricant Use: Dry Eye

Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured by Laboratorios Sophia on the ocular surface of clinically healthy subjects.

Hypothesis:

H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile similar to Lagricel® Ofteno single dose in healthy subjects.

H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability profile than Lagricel® Ofteno single dose in healthy subjects.

Main inclusion criteria: Clinically healthy subjects


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Presence of Adverse Events (AEs)
timeFrame: during the 10 days of evaluation, including the safety call (day 11).
measure: Eye Comfort Index (ECI)
timeFrame: will be evaluated at the end of the treatment (day 8, final visit)
Secondary outcomes:
measure: Visual Acuity (VA)
timeFrame: will be evaluated at the end of the treatment (day 8, final visit)
measure: Epithelial Defects (ED) Fluorescein Stain
timeFrame: will be evaluated at the end of the treatment (day 8, final visit)
measure: Epithelial Defects (ED) Green Lissamine
timeFrame: will be evaluated at the end of the treatment (day 8, final visit)
measure: Conjunctival Hyperemia (CH)
timeFrame: will be evaluated at the end of the treatment (day 8, final visit)
measure: Chemosis
timeFrame: will be evaluated at the end of the treatment (day 8, final visit)
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Biomedical research G & LS de RL de CV
state: Jalisco
Study officials:
affiliation: Laboratorios Sophia S.A de C.V.
name: Leopoldo Baiza Durán, MD
role: STUDY_DIRECTOR
References:
citation: Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.