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

NCT04081610 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH037-0119/I
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye

Keywords

Dry eye; eye lubricant; sodium hyaluronate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Visual Acuity (VA)

  will be evaluated at the end of the treatment (day 8, final visit)

• Epithelial Defects (ED) Fluorescein Stain

  will be evaluated at the end of the treatment (day 8, final visit)

• Epithelial Defects (ED) Green Lissamine

  will be evaluated at the end of the treatment (day 8, final visit)

• Conjunctival Hyperemia (CH)

  will be evaluated at the end of the treatment (day 8, final visit)

• Chemosis

  will be evaluated at the end of the treatment (day 8, final visit)

Study Arms (2)

Lagricel® Ofteno Multidose

EXPERIMENTAL

Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia

Drug: lagricel ofteno multidose

Lagricel® Ofteno Single dose

ACTIVE COMPARATOR

Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia

Drug: lagricel ofteno single dose

Interventions

lagricel ofteno multidose DRUG

* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic

Also known as: sodium hyaluronate 0.4%

Lagricel® Ofteno Multidose

lagricel ofteno single dose DRUG

* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic

Also known as: sodium hyaluronate 0.4%

Lagricel® Ofteno Single dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 previously participated in this same study.
• To be a user of contact lenses and can not suspend their use during the 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.

Sponsors & Collaborators

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

Study Sites (1)

Biomedical research G & LS de RL de CV

Guadalajara, Jalisco, 45070, Mexico

Location

Related Publications (1)

• 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.

  PMID: 34707360 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Alejandra Sanchez-Rios
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

+52 (33) 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, controlled, parallel group, open, randomized

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: September 9, 2019
• Primary Completion: October 23, 2019
• Study Completion: November 13, 2019
• Last Updated: May 3, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)