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Completed

NCT Number: NCT04702776

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Guadalajara, Jalisco, 44190, Mexico

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being capable of voluntarily grant a signed informed consent.
  • Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
  • Age ≥ 18 years old
  • Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed 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 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 conjunctival surface.
  • Any retinal or posterior segment diseases that require treatment or threat the visual outcome.
  • Glaucoma
  • Any palpebral alteration that causes eyelid malposition, limiting the adequate closure or aperture of this structures, or that cause tearing.
  • Requiring management for dry eye that includes implementation of treatments described in the step 2 management recommendations of the Tear Film & Ocular Surface Society's Dry Eye Work Shop II (TFO DEWS II).
  • Previous history of drug addiction within the last 2 years prior to signing this study'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 contact lenses is suspended both during the study period and at least 15 days prior inclusion takes place.
  • Previous history of any medical affliction, acute or chronic, that according to the investigator may increase either the risk to the patient for participating in this study 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.

Treatment and study plan

Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%

Drug

Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.

Other names: Humylub Ofteno® PF, PRO-087

Sodium hyaluronate 0.15%

Drug

Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.

Other names: Hyabak® PF

Sodium hyaluronate 0.4%

Drug

Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.

Other names: Lagricel Ofteno® PF, PRO-037

Primary outcomes

  1. Change in Ocular Surface Disease Index (OSDI)

    Time frame: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

    OSDI is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). A higher score is a worse outcome. • This outcome measure considered the Per Protocol (PP) population.

Secondary outcomes

  1. Noninvasive Keratograph Break-up Time (NIKBUT)

    Time frame: Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

    This evaluation will be performed through an Oculus Keratograph 5M, and the parameter "first break-up time" will be recorded as NIKBUT. A lower value is a worse outcome. This outcome measure considered the Per Protocol (PP) population.

  2. Change of Conjunctival and Corneal Staining With Lissamine Green

    Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

    The change in proportion of participant's abscence of conjunctival and corneal staining with lissamine green will be analyzed. The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). This outcome measure considered the Per Protocol (PP) population.

  3. Change of Conjunctival and Corneal Staining With Fluorescein

    Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

    The change in proportion of participant's abscence of conjunctival and corneal staining with fluorescein will be analyzed. The evaluation will take place after applying the fluorescein stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). This outcome measure considered the Per Protocol (PP) population.

  4. Change in Conjunctival Hyperemia

    Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

    The change in proportion of participant's score will be analyzed. Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4). This outcome measure considered the Per Protocol (PP) population.

  5. Incidence of Related Non Expected Adverse Events

    Time frame: Days: 0 (eligibility visit), 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), 31 - 33 (± 1) (final visit), and 38 - 40 (± 1) (safety call).

    Number of related non expected adverse events observed per group. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

  6. Change in Best Corrected Visual Acuity (BCVA)

    Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

    With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc.

    Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. 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. This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.

  7. Change in Incidence of Chemosis

    Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

    Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent per subject. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

Non Inferiority Phase IV Clinical Study, to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF Against Hyabak® and Lagricel Ofteno® PF When Applied on the Ocular Surface of Patients With Mild to Moderate Dry Eye.

Acronym: PRO-087

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2021
Registry last updated
Feb 20, 2026

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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