Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution (PRO-037)

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 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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: lagricel ofteno multidose; Drug: lagricel ofteno single dose

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 45070
      • Biomedical research G & LS de RL de CV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): October 23, 2019
• Study Completion (Actual): November 13, 2019

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Dry eye; sodium hyaluronate; eye lubricant
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: SOPH037-0119/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Laboratorios Sophia, S.A. de C.V., serving as the sponsor of the study, assumes full responsibility for its function and retains exclusive ownership rights over the results of the study.

The principal investigator undertakes not to publish or communicate data collected from the study, unless there is prior written agreement of Laboratorios Sophia, S.A. de C.V.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No