Eye drop showdown: which one beats dry eye?
NCT ID NCT04702776
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested three different eye drops (Humylub Ofteno PF, Hyabak, and Lagricel Ofteno PF) in 182 people with mild to moderate dry eye. Participants used the drops four times a day for 30 days. The main goal was to see if Humylub was as good as the others at reducing dry eye symptoms, measured by a standard questionnaire. The study also looked at tear film stability using a special camera.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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182 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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May 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
Guadalajara, Jalisco, 44190, Mexico
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