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

Phase 1

Completed

Conditions: Dry Eye

Interventions: Drug: lagricel ofteno multidose
Drug: lagricel ofteno single dose

Registration Number: NCT04081610

Lead Sponsor: Laboratorios Sophia S.A de C.V.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lagricel® Ofteno Multidose	lagricel ofteno multidose	Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
Lagricel® Ofteno Single dose	lagricel ofteno single dose	Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia

Primary Outcome Measures

Name	Time	Method
Presence of Adverse Events (AEs)	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)	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 Outcome Measures

Name	Time	Method
Conjunctival Hyperemia (CH)	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.
Epithelial Defects (ED) Fluorescein Stain	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.
Visual Acuity (VA)	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) Green Lissamine	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.
Chemosis	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