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Can more drops beat dry eye? new study tests three schedules

NCT ID NCT04704531

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 study tested three different dosing schedules of Lagricel Ofteno eye drops (sodium hyaluronate 0.4%) in 141 people with mild to moderate dry eye. Participants used the drops either twice, four times, or six times a day. The main goal was to see which schedule best improved eye comfort and surface health, while also checking for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sodium hyaluronate 0.4% eye drops (Lagricel Ofteno)
What this could lead to
If successful, this could help identify the best dosing schedule for sodium hyaluronate eye drops to relieve dry eye symptoms.
What could go wrong
This is an early Phase 2 trial with a small number of participants, so results may not apply to everyone. Different dosing schedules may show similar effects, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

141 people

The number who actually took part.

Started

Jan 2022

Finished

Jun 2022

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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

  • Instituto Jalisciense del Metabolismo, S.C.

    Guadalajara, Jalisco, 44670, Mexico

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Other studies related to the condition(s) this trial covers.