Clinical trial NCT04702776: 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.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase IV, non inferiority, controlled, open, comparative, multicenter clinical study
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI)
timeFrame: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary outcomes:
measure: Noninvasive keratograph break-up time (NIKBUT)
timeFrame: Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
measure: Change in conjunctival and corneal staining with lissamine green
timeFrame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
measure: Change in conjunctival and corneal staining with fluorescein
timeFrame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
measure: Change in conjunctival hyperemia
timeFrame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
measure: Incidence of related non expected adverse events
timeFrame: 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).
measure: Change in Best Corrected Visual Acuity (BCVA)
timeFrame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
measure: Change in incidence of chemosis
timeFrame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
state: Jalisco
Study officials:
References: