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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2023-05-15

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase IV, non inferiority, controlled, open, comparative, multicenter clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

After signing the informed consent form (ICF), every subject will receive a coded patient number and will be assigned randomly to one of the investigation products.

Study Groups

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Arm 1; Humylub Ofteno® PF

Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.

Group Type EXPERIMENTAL

Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%

Intervention Type 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.

Arm 2; Hyabak®

Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.

Group Type ACTIVE_COMPARATOR

Sodium hyaluronate 0.15%

Intervention Type DRUG

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

Arm 3; Lagricel Ofteno® PF

Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.

Group Type ACTIVE_COMPARATOR

Sodium hyaluronate 0.4%

Intervention Type DRUG

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

Interventions

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Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%

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

Intervention Type DRUG

Sodium hyaluronate 0.15%

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

Intervention Type DRUG

Sodium hyaluronate 0.4%

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

Intervention Type DRUG

Other Intervention Names

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Humylub Ofteno® PF PRO-087 Hyabak® PF Lagricel Ofteno® PF PRO-037

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No