Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease

NCT07722650 | Completed

• 1 other identifier: HPH-DED-SYS-2026-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (day 0) to day 30 of treatment

Secondary Outcomes (4)

• Change in tear break-up time (TBUT) from baseline to day 30

  Baseline and day 30 after start of treatment

• Change in Schirmer test value from baseline to day 30

  Baseline and day 30 after start of treatment

• Change in Oxford corneal and conjunctival staining score from baseline to day 30

  Baseline and day 30 after start of treatment

• Treatment adherence over 30 days of follow-up

  Day 15 and day 30 of treatment

Study Arms (2)

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.

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.

Drug: Thealoz Duo

Interventions

Systane Complete DRUG

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.

Also known as: Lipid-containing artificial tears

Systane Complete twice daily

Thealoz Duo DRUG

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.

Also known as: Hyaluronic acid and trehalose ophthalmic solution

Thealoz Duo four times daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Internacional de Medicina y Terapia (IIMET): lead
• Hospital Puerta de Hierro, Zapopan: collaborator
• Centro de Retina Médica y Quirúrgica S.C.: collaborator

Study Sites (1)

Hospital Puerta de Hierro

Zapopan, Jalisco, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Dalia Denisse Ng-Aleman, MD

  Hospital Puerta de Hierro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label design due to differences in commercial presentation and dosing frequency of the study medications.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist and Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: January 6, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)