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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: lagricel ofteno multidose
* Drug: lagricel ofteno single dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-center, controlled, parallel group, open, randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lagricel® Ofteno Multidose<br>Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia | Drug: lagricel ofteno multidose<br>* Dosage: 1 drop 4 times a day per 7 days, both eyes Route of administration: Ophthalmic<br>* Other names: sodium hyaluronate 0.4%;|
| Active Comparator: Lagricel® Ofteno Single dose<br>Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia | Drug: lagricel ofteno single dose<br>* Dosage: 1 drop 4 times a day per 7 days, both eyes Route of administration: Ophthalmic<br>* Other names: sodium hyaluronate 0.4%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Adverse Events (AEs) | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent | during the 10 days of evaluation, including the safety call (day 11). | 
| Eye Comfort Index (ECI) | 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). | will be evaluated at the end of the treatment (day 8, final visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity (VA) | 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. | will be evaluated at the end of the treatment (day 8, final visit) | 
| Epithelial Defects (ED) Fluorescein Stain | 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. | will be evaluated at the end of the treatment (day 8, final visit) | 
| Epithelial Defects (ED) Green Lissamine | 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. | will be evaluated at the end of the treatment (day 8, final visit) | 
| Conjunctival Hyperemia (CH) | 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. | will be evaluated at the end of the treatment (day 8, final visit) | 
| Chemosis | 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 | will be evaluated at the end of the treatment (day 8, final visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, eye lubricant, sodium hyaluronate