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Completed

NCT Number: NCT04704531

Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease.

Phase II, comparative, controlled, multicenter, parallel group, open, randomized clinical study. The main outcome variable will be the Ocular Surface Disease Index (OSDI) questionnaire. Three dosage schemes of topical ophthalmic application of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%; preservative free) are to be evaluated in patients diagnosed with mild to severe dry eye. Each group will be exposed to one of the following administration schemes: 1 drop bis in die (BID), 1 drop quater in die (QID), or 1 drop six times per day; instillation will take place in both eyes (OU).

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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 2

Primary location

Instituto Jalisciense del Metabolismo, S.C.

Guadalajara, Jalisco, 44670, Mexico

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years old.
  • 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.
  • 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 between 13 and 32, plus one of the following:
  • More than 5 dots of corneal staining
  • More than 9 dots of conjunctival staining
  • Tear Break-up Time (BUT) < 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 signing this study's informed consent form.
  • Having participated previously in this study.
  • Best Corrected Visual Acuity (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 ocular 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
  • 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 Ophthalmic 0.4% one drop twice a day (BID)

Drug

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.

Other names: PRO-037, Lagricel® Ofteno

Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)

Drug

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.

Other names: PRO-037, Lagricel® Ofteno

Sodium Hyaluronate Ophthalmic 0.4% Six times per day

Drug

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.

Other names: PRO-037, Lagricel® Ofteno

Primary outcomes

  1. Change in Ocular Surface Disease Index (OSDI)

    Time frame: Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).

    OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.

  2. Incidence of Adverse Events (AE)

    Time frame: Up to Day 33 (+ 1) (safety call).

    Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution and whether it was considered related or not to the investigation products.

Secondary outcomes

  1. Change in Tear Break-up Time (BUT)

    Time frame: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

    After application of fluorescein stain, using a slit lamp and its cobalt blue filter, the time elapsed after instructing the patient to blink 1 or 2 times and the appearance of dry spots on the ocular surface will be counted and reported as BUT. Normally, this parameter is ≥ 10 seconds.

  2. Change in Conjunctival and Corneal Staining With Lissamine Green

    Time frame: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

    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).

  3. Change in Conjunctival and Corneal Staining With Fluorescein

    Time frame: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

    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).

  4. Change in Conjunctival Hyperemia

    Time frame: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

    Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (III), and Severe (IV).

  5. Incidence of Chemosis

    Time frame: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

    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. This evaluation will be made taking in consideration the counts of "absent" seen per counts of eyes and per visit.

  6. Change in Best Corrected Visual Acuity (BCVA)

    Time frame: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).

    With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or 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. The normal score for a VA is 20/20.This score is expressed in decimal (i.e. 1.0) format. In decimal format, a lower number is a worse outcome.

  7. Change in Intraocular Pressure (IOP)

    Time frame: BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit).

    Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP will be evaluated. Normal values are considered between 10 and 21 mmHg.

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution Applied in Three Different Dosage Schemes as Treatment for Mild to Moderate Dry Eye

Acronym: PRO-037

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2021
Registry last updated
Mar 3, 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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