Dry Eye Syndrome (DES)NCT07722650
Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease
A study testing Systane Complete and Thealoz Duo in people with Dry Eye Syndrome (DES) and Ocular Surface Disease, run by Instituto Internacional de Medicina y Terapia (IIMET) at 1 site in Mexico.
Trial summary
The goal of this clinical trial is to learn whether a twice-daily dosing schedule of Systane Complete eye drops works as well as a four-times-daily dosing schedule of Thealoz Duo eye drops to treat dry eye disease in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome (DES), Ocular Surface Disease
- What is being tested?
- Systane Complete and Thealoz Duo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease: A Randomized Controlled Non-Inferiority Trial
The goal of this clinical trial is to learn whether a twice-daily dosing schedule of Systane Complete eye drops works as well as a four-times-daily dosing schedule of Thealoz Duo eye drops to treat dry eye disease in adults. The main questions it aims to answer are:
- Does twice-daily Systane Complete provide similar improvement in dry eye symptoms, measured by the Ocular Surface Disease Index (OSDI), compared with four-times-daily Thealoz Duo after 30 days of treatment?
- How do the treatments affect tear film stability, tear production, and damage to the surface of the eye?
Read more
Researchers will compare Systane Complete (used twice a day) to Thealoz Duo (used four times a day) to see if the simpler dosing schedule maintains similar benefits for symptoms and eye surface health.
Participants will be adults with mild to moderate dry eye disease who are seen in an outpatient eye clinic. They will be randomly assigned to one of the two treatment groups. All participants will use their assigned eye drops in both eyes for 30 days and will attend clinic visits at the start of the study and after 30 days. At each visit, participants will complete the OSDI questionnaire and undergo standard eye tests, including tear break-up time, Schirmer test, and grading of surface staining on the eye.
- Conditions
- Dry Eye Syndrome (DES), Ocular Surface Disease
- Being tested
- Systane Complete, Thealoz Duo
- Keywords
- dry eye disease, Artificial tears, Systane Complete, Tear break-up time, Thealoz Duo, Non-inferiority trial, Ocular Surface Disease Index (OSDI)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane CompleteDrug
Also called Lipid-containing artificial tears
Systane Complete is a commercially available lipid-containing artificial tear formulation that combines mineral oils with nano-droplet lipid technology to support all three layers of the tear film (lipid, aqueous, and mucin). In this study, participants assigned to this intervention will instill one to two drops in each eye twice daily for 30 days, maintaining a minimum interval of eight hours between doses and avoiding additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators.
Thealoz DuoDrug
Also called Hyaluronic acid and trehalose ophthalmic solution
Thealoz Duo is a commercially available ophthalmic solution that combines hyaluronic acid with trehalose to protect the ocular surface and support epithelial recovery in dry eye disease. In this study, participants assigned to this intervention will instill one to two drops in each eye four times daily for 30 days, maintaining a minimum interval of four hours between doses and avoiding additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators.
| Study group | Role | What they receive |
|---|---|---|
| Systane Complete twice daily | Experimental | Participants in this arm will instill one to two drops of Systane Complete in each eye twice daily for 30 days. They will be instructed to maintain a minimum interval of eight hours between doses and to avoid using additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators. Receives: Drug: Systane Complete |
| Thealoz Duo four times daily | Active comparator | Participants in this arm will instill one to two drops of Thealoz Duo in each eye four times daily for 30 days. They will be instructed to maintain a minimum interval of four hours between doses and to avoid using additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators. Receives: Drug: Thealoz Duo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire that measures the frequency of dry eye symptoms and their impact on visual function and daily activities. Scores range from 0 to 100, with higher scores indicating more severe symptoms. In this trial, participants complete the OSDI at baseline and after 30 days of treatment. The primary outcome is the adjusted mean OSDI score at day 30, analyzed using analysis of covariance (ANCOVA) with baseline OSDI as a covariate to compare twice-daily Systane Complete with four-times-daily Thealoz Duo within a non-inferiority framework.
Measured: From baseline (day 0) to day 30 of treatment
Secondary outcomes (4)
Change in tear break-up time (TBUT) from baseline to day 30
Tear break-up time (TBUT) is measured using fluorescein dye as the interval in seconds between a complete blink and the first appearance of a discontinuity in the tear film. TBUT is assessed in both eyes at baseline and at day 30 under controlled environmental conditions; values from the right and left eyes are averaged to obtain a single patient-level value. The secondary outcome is the change in mean TBUT (seconds) from baseline to day 30 and the between-group comparison of TBUT at day 30.
Measured: Baseline and day 30 after start of treatment
Change in Schirmer test value from baseline to day 30
Schirmer test without anesthesia is used to assess tear production by placing filter paper strips in the lower eyelid for 5 minutes and measuring the length of wetting in millimeters. Schirmer test is performed in both eyes at baseline and at day 30; measurements from right and left eyes are averaged to generate a single patient-level value. The secondary outcome is the change in mean Schirmer test value (millimeters) from baseline to day 30 and the between-group comparison of Schirmer values at day 30.
Measured: Baseline and day 30 after start of treatment
Change in Oxford corneal and conjunctival staining score from baseline to day 30
Corneal and conjunctival epithelial staining is evaluated using fluorescein and graded according to the Oxford grading scale for ocular surface staining. The Oxford scale ranges from grade 0 (no staining) to grade 5 (severe staining), with higher grades indicating more extensive epithelial damage. Staining is assessed in both eyes at baseline and at day 30; scores from the right and left eyes are averaged to obtain a single patient-level value. The secondary outcome includes the change in mean Oxford staining score from baseline to day 30 and the proportion of participants achieving complete resolution of corneal staining (Oxford grade 0) at day 30 in each treatment group.
Measured: Baseline and day 30 after start of treatment
Treatment adherence over 30 days of follow-up
Treatment adherence is evaluated using patient-completed daily treatment diaries that record each administration of the assigned study medication. Adherence (%) is calculated using the formula AD = (RA × 100) / IA, where RA is the number of recorded administrations and IA is the total number of indicated applications according to the prescribed dosing regimen. Adherence is assessed at day 15 and day 30. Participants with adherence values below 90% are considered to have protocol deviations and are excluded from the per-protocol analysis.
Measured: Day 15 and day 30 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start6 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group, active-controlled, non-inferiority trial comparing twice-daily Systane Complete with four-times-daily Thealoz Duo over 30 days in adults with mild to moderate dry eye disease.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Internacional de Medicina y Terapia (IIMET)
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Puerta de Hierro, Zapopan, Centro de Retina Médica y Quirúrgica S.C.
- Responsible party
- Principal investigator, Jose Navarro Partida, Instituto Internacional de Medicina y Terapia (IIMET)
- Investigators
- Dalia Denisse Ng-Aleman, MD, Principal investigator, Hospital Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722650
- Sponsor's protocol ID
- HPH-DED-SYS-2026-01
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analysed during the current study are not publicly available due to institutional and patient privacy restrictions, but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease: A Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07722650
- Acronym / sponsor ID
- HPH-DED-SYS-2026-01
- Conditions
- Dry Eye Syndrome (DES), Ocular Surface Disease
- Keywords
- dry eye disease, Artificial tears, Systane Complete, Tear break-up time, Thealoz Duo, Non-inferiority trial, Ocular Surface Disease Index (OSDI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto Internacional de Medicina y Terapia (IIMET)University, hospital or other
- Collaborators
- Hospital Puerta de Hierro, Zapopan, Centro de Retina Médica y Quirúrgica S.C.
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a twice-daily dosing schedule of Systane Complete eye drops works as well as a four-times-daily dosing schedule of Thealoz Duo eye drops to treat dry eye disease in adults. The main questions it aims to answer are:
- Does twice-daily Systane Complete provide similar improvement in dry eye symptoms, measured by the Ocular Surface Disease Index (OSDI), compared with four-times-daily Thealoz Duo after 30 days of treatment?
- How do the treatments affect tear film stability, tear production, and damage to the surface of the eye?
Researchers will compare Systane Complete (used twice a day) to Thealoz Duo (used four times a day) to see if the simpler dosing schedule maintains similar benefits for symptoms and eye surface health.
Participants will be adults with mild to moderate dry eye disease who are seen in an outpatient eye clinic. They will be randomly assigned to one of the two treatment groups. All participants will use their assigned eye drops in both eyes for 30 days and will attend clinic visits at the start of the study and after 30 days. At each visit, participants will complete the OSDI questionnaire and undergo standard eye tests, including tear break-up time, Schirmer test, and grading of surface staining on the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel-group, active-controlled, non-inferiority trial comparing twice-daily Systane Complete with four-times-daily Thealoz Duo over 30 days in adults with mild to moderate dry eye disease.
| Arm | Type | Receives |
|---|---|---|
| Systane Complete twice daily | Experimental | Drug: Systane CompleteParticipants in this arm will instill one to two drops of Systane Complete in each eye twice daily for 30 days. They will be instructed to maintain a minimum interval of eight hours between doses and to avoid using additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators. |
| Thealoz Duo four times daily | Active comparator | Drug: Thealoz DuoParticipants in this arm will instill one to two drops of Thealoz Duo in each eye four times daily for 30 days. They will be instructed to maintain a minimum interval of four hours between doses and to avoid using additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systane CompleteAlso: Lipid-containing artificial tearsSystane Complete is a commercially available lipid-containing artificial tear formulation that combines mineral oils with nano-droplet lipid technology to support all three layers of the tear film (lipid, aqueous, and mucin). In this study, participants assigned to this intervention will instill one to two drops in each eye twice daily for 30 days, maintaining a minimum interval of eight hours between doses and avoiding additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators. | Drug | Systane Complete twice daily |
| Thealoz DuoAlso: Hyaluronic acid and trehalose ophthalmic solutionThealoz Duo is a commercially available ophthalmic solution that combines hyaluronic acid with trehalose to protect the ocular surface and support epithelial recovery in dry eye disease. In this study, participants assigned to this intervention will instill one to two drops in each eye four times daily for 30 days, maintaining a minimum interval of four hours between doses and avoiding additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators. | Drug | Thealoz Duo four times daily |
Primary outcome
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
Time frame: From baseline (day 0) to day 30 of treatment
The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire that measures the frequency of dry eye symptoms and their impact on visual function and daily activities. Scores range from 0 to 100, with higher scores indicating more severe symptoms. In this trial, participants complete the OSDI at baseline and after 30 days of treatment. The primary outcome is the adjusted mean OSDI score at day 30, analyzed using analysis of covariance (ANCOVA) with baseline OSDI as a covariate to compare twice-daily Systane Complete with four-times-daily Thealoz Duo within a non-inferiority framework.
4 secondary outcomes
Change in tear break-up time (TBUT) from baseline to day 30
Time frame: Baseline and day 30 after start of treatment
Change in Schirmer test value from baseline to day 30
Time frame: Baseline and day 30 after start of treatment
Change in Oxford corneal and conjunctival staining score from baseline to day 30
Time frame: Baseline and day 30 after start of treatment
Treatment adherence over 30 days of follow-up
Time frame: Day 15 and day 30 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. The datasets generated and analysed during the current study are not publicly available due to institutional and patient privacy restrictions, but are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Denisse Ng-Aleman, MD principal investigator
Hospital Puerta de Hierro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Complete and Thealoz Duo in people with Dry Eye Syndrome (DES) and Ocular Surface Disease, run by Instituto Internacional de Medicina y Terapia (IIMET) at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30 (time frame: From baseline (day 0) to day 30 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.