Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 23, 2019

Interventions

  • Drug: lagricel ofteno multidose
    • Dosage: 1 drop 4 times a day per 7 days, both eyes Route of administration: Ophthalmic
  • Drug: lagricel ofteno single dose
    • Dosage: 1 drop 4 times a day per 7 days, both eyes Route of administration: Ophthalmic

Arms, Groups and Cohorts

  • Experimental: Lagricel® Ofteno Multidose
    • Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
  • Active Comparator: Lagricel® Ofteno Single dose
    • Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia

Clinical Trial Outcome Measures

Primary Measures

  • Presence of Adverse Events (AEs)
    • Time Frame: during the 10 days of evaluation, including the safety call (day 11).
    • the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
  • Eye Comfort Index (ECI)
    • Time Frame: will be evaluated at the end of the treatment (day 8, final visit)
    • It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).

Secondary Measures

  • Visual Acuity (VA)
    • Time Frame: will be evaluated at the end of the treatment (day 8, final visit)
    • Visual acuity (VA) is a test of visual function. It will be evaluated at baseline, without refractive correction with the Snellen chart.Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3meters from the subject to be evaluated. The snellen chart consists of a booklet with 11 lines composed of letters, each line has a different size and a different weighting. the subject is placed at a safe distance and the contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.
  • Epithelial Defects (ED) Fluorescein Stain
    • Time Frame: will be evaluated at the end of the treatment (day 8, final visit)
    • The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
  • Epithelial Defects (ED) Green Lissamine
    • Time Frame: will be evaluated at the end of the treatment (day 8, final visit)
    • The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
  • Conjunctival Hyperemia (CH)
    • Time Frame: will be evaluated at the end of the treatment (day 8, final visit)
    • Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as 0.-Normal / 1.-Very Light/ 2.- Light/ 3.-Mild / 4.-Moderate / 5.- Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
  • Chemosis
    • Time Frame: will be evaluated at the end of the treatment (day 8, final visit)
    • It is defined as conjunctival edema, the result of an inflammatory reaction. It is qualified as present or absent. The evaluator will use a narrow beam of light at 60 ° and will measure if the conjunctiva separates from the sclera by ≥ 1/3 of the total eyelid opening

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Laboratorios Sophia S.A de C.V.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Leopoldo Baiza Durán, MD, Study Director, Laboratorios Sophia S.A de C.V.

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