Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Intervention: lagricel ofteno multidose; lagricel ofteno single dose
Intervention description: Dosage: 1 drop 4 times a day per 7 days, both eyes
Route of administration: Ophthalmic; Dosage: 1 drop 4 times a day per 7 days, both eyes
Route of administration: Ophthalmic
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, controlled, parallel group, open, randomized
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dry eye; eye lubricant; sodium hyaluronate

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
    

Eligibility criteria:

        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.