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Fewer drops, same relief? trial tests Twice-Daily systane complete against standard Four-Times-Daily regimen

NCT ID NCT07722650

Symptom relief Sponsor: Instituto Internacional de Medicina y Terapia (IIMET) Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial investigates whether using Systane Complete eye drops twice a day works as well as using Thealoz Duo eye drops four times a day for adults with mild to moderate dry eye disease. Over 30 days, participants will use one of the two regimens and report symptom changes through a questionnaire, while doctors measure tear film stability and eye surface health. The goal is to see if a simpler dosing schedule can provide comparable symptom relief.

What this could mean

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

Active substance
lipid-containing artificial tears (Systane Complete) compared to another artificial tear (Thealoz Duo)
What this could lead to
If successful, this could offer a simpler, less frequent dosing option for managing dry eye symptoms.
What could go wrong
This is a small, short-term trial comparing two existing products, so any advantage may be modest or not apply to all dry eye patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Jan 2025

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Adults (≥18 years of age) with mild to moderate dry eye disease (DED). * Ocular Surface Disease Index (OSDI) score between 13 and 32 at baseline. * At least one abnormal objective test of ocular surface dysfunction, defined as one or more of the following: * Schirmer test result \< 10 mm in 5 minutes (without anesthesia), or * Tear break-up time (TBUT) \< 10 seconds, or * Ocular surface staining graded between stages 1 and 3 according to the Oxford scale. * Best-corrected visual acuity of 20/200 or better in both eyes. * Able to provide written informed consent and comply with study procedures and scheduled visits. Exclusion Criteria: * Pregnancy or breastfeeding. * Participation in another clinical trial or prior participation in the present study. * Best-corrected visual acuity worse than 20/200 in either eye. * Active ocular disease including conjunctivitis, blepharitis, keratitis, ocular trauma, ocular surface scarring, corneal ulcers, neurotrophic keratitis, bullous keratopathy, or neoplastic disease of the ocular surface. * Glaucoma or eyelid disorders that affect normal eyelid function. * Advanced dry eye disease requiring second-line TFOS DEWS II therapy. * Ocular surgery within the previous 3 months. * Contact lens use within 15 days prior to enrollment. * Known hypersensitivity to any component of the study medications. * Substance dependence within the previous 2 years. * Systemic conditions that could increase the risk of study participation or interfere with interpretation of study outcomes, as judged by the investigators. * Women of childbearing potential not using stable contraceptive methods for at least 30 days prior to enrollment and throughout the study duration.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye syndrome (DES) Ocular surface disease

Contacts and locations

Locations

  • Hospital Puerta de Hierro

    Zapopan, Jalisco, Mexico

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