Clinical trial NCT04704531: Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative, controlled, multicenter, open, randomized clinical study.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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
    * 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.
* 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.

Primary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI)
timeFrame: Days: 0 (baseline visit) and 31 (+1) (final visit),
measure: Incidence of adverse events
timeFrame: Day 33 (+ 1) (safety call).
Secondary outcomes:
measure: Change in tear break-up time (BUT)
timeFrame: Days: 0 (baseline visit),15 (± 1) (first follow-up visit), and 31 (+ 1) (final visit).
measure: Change in conjunctival and corneal staining with lissamine green
timeFrame: Days: 0 (baseline visit),15 (± 1) (first follow-up visit), and 31 (+ 1) (final visit).
measure: Change in conjunctival and corneal staining with fluorescein
timeFrame: Days: 0 (baseline visit),15 (± 1) (first follow-up visit), and 31 (+ 1) (final visit).
measure: Change in conjunctival hyperemia
timeFrame: Days: 0 (baseline visit),15 (± 1) (first follow-up visit), and 31 (+ 1) (final visit).
measure: Change in incidence of chemosis
timeFrame: Days: 0 (baseline visit),15 (± 1) (first follow-up visit), and 31 (+ 1) (final visit).
measure: Change in Best Corrected Visual Acuity (BCVA)
timeFrame: Days: 0 (baseline visit),15 (± 1) (first follow-up visit), and 31 (+ 1) (final visit).
measure: Change in intraocular Pressure (IOP)
timeFrame: Days: 0 (baseline visit),15 (± 1) (first follow-up visit), and 31 (+ 1) (final visit).
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense del Metabolismo, S.C.
state: Jalisco
Study officials:
References: