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Completed

NCT Number: NCT04081610

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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biomedical research G & LS de RL de CV

Guadalajara, Jalisco, 45070, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lagricel ofteno multidose

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

Other names: sodium hyaluronate 0.4%

lagricel ofteno single dose

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

Other names: sodium hyaluronate 0.4%

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

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

Acronym: PRO-037

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2019
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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