Phase IV Clinical Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye.

Last updated: January 3, 2024
Sponsor: Laboratorios Sophia S.A de C.V.
Overall Status: Completed

Phase

4

Condition

Eyelid Inflammation

Dry Eye Disease

Sjogren's Syndrome

Treatment

Sodium hyaluronate 0.15%

Sodium hyaluronate 0.4%

Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%

Clinical Study ID

NCT04702776
SOPH087-0120/IV
  • Ages > 18
  • All Genders

Study Summary

Phase IV, non inferiority, controlled, open, multicenter clinical study to compare the efficacy of the Ophthalmic Solution Humylub Ofteno® PF against Hyabak® and Lagricel Ofteno® PF applied quater in die (QID) for 30 days in patients with mild to moderate dry eye disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Being capable of voluntarily grant a signed informed consent.
  • Being willing and able to meet the requirements of the study such as attendingprogrammed visits, treatment plan and other study procedures.
  • Age ≥ 18 years old
  • Women in child-bearing age must assure the continuation (start ≥ 30 days prior toinformed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.
  • Presenting a mild to moderate dry eye disease diagnosis, defined as:
  • OSDI score ≥ 13, plus one of the following:
  • More than 5 dots of corneal staining
  • More than 9 dots of conjunctival staining
  • Tear break-up time < 10 seconds

Exclusion

Exclusion Criteria:

    • Pregnancy, breastfeeding or planning to become pregnant during the time of the study
  • Having participated in clinical trials within 30 days prior to the eligibility visit.
  • Having participated previously in this study.
  • BCVA equal or worse than 20/200, in either eye.
  • Diagnosis of any of the following:
  • Allergic, viral or bacterial conjunctivitis
  • Anterior blepharitis
  • Parasite infestation of any ocular or annex structures (Demodex, for example)
  • Unresolved history of ocular trauma
  • Scarring diseases of the ocular surface
  • Corneal or conjunctival ulcers
  • Filamentary keratitis
  • Neurotrophic keratitis
  • Bullous keratopathy
  • Neoplastic diseases of the ocular surface or ocular annexes
  • Diseases presenting fibrovascular proliferations on the corneal or conjunctivalsurface.
  • Any retinal or posterior segment diseases that require treatment or threat thevisual outcome.
  • Glaucoma
  • Any palpebral alteration that causes eyelid malposition, limiting the adequateclosure or aperture of this structures, or that cause tearing.
  • Requiring management for dry eye that includes implementation of treatments describedin the step 2 management recommendations of the Tear Film & Ocular Surface Society'sDry Eye Work Shop II (TFO DEWS II).
  • Previous history of drug addiction within the last 2 years prior to signing thisstudy's informed consent form.
  • Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date.
  • Being a contact lens user, rigid or soft. Inclusion is possible if the use of contactlenses is suspended both during the study period and at least 15 days prior inclusiontakes place.
  • Previous history of any medical affliction, acute or chronic, that according to theinvestigator may increase either the risk to the patient for participating in thisstudy or the risk of interference of the accurate interpretation of results.
  • Known hypersensitivity to any of the components of the products used in this study.

Study Design

Total Participants: 135
Treatment Group(s): 3
Primary Treatment: Sodium hyaluronate 0.15%
Phase: 4
Study Start date:
December 09, 2021
Estimated Completion Date:
May 15, 2023

Connect with a study center

  • Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

    Guadalajara, Jalisco 44190
    Mexico

    Site Not Available

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