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

23. Juli 2026 aktualisiert von: Jose Navarro Partida, Instituto Internacional de Medicina y Terapia (IIMET)

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?

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Mexiko
    • Jalisco
      • Zapopan, Jalisco, Mexiko
        • Hospital Puerta de Hierro

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Systane Complete twice daily
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.
Arzneimittel: Systane Complete
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.
Andere Namen:
  • Lipid-containing artificial tears
Aktiver Komparator: Thealoz Duo four times daily
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.
Arzneimittel: Thealoz Duo
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.
Andere Namen:
  • Hyaluronic acid and trehalose ophthalmic solution

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
Zeitfenster: 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.
From baseline (day 0) to day 30 of treatment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in tear break-up time (TBUT) from baseline to day 30
Zeitfenster: Baseline and day 30 after start of treatment
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.
Baseline and day 30 after start of treatment
Change in Schirmer test value from baseline to day 30
Zeitfenster: Baseline and day 30 after start of treatment
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.
Baseline and day 30 after start of treatment
Treatment adherence over 30 days of follow-up
Zeitfenster: Day 15 and day 30 of treatment
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.
Day 15 and day 30 of treatment
Change in Oxford corneal and conjunctival staining score from baseline to day 30
Zeitfenster: Baseline and day 30 after start of treatment
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.
Baseline and day 30 after start of treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Instituto Internacional de Medicina y Terapia (IIMET)

Mitarbeiter

Centro de Retina Médica y Quirúrgica S.C.
Hospital Puerta de Hierro, Zapopan

Ermittler

  • Hauptermittler: Dalia Denisse Ng-Aleman, MD, Hospital Puerta de Hierro

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Januar 2025

Primärer Abschluss (Tatsächlich)

30. Juni 2025

Studienabschluss (Tatsächlich)

30. Juni 2025

Studienanmeldedaten

Zuerst eingereicht

19. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Juli 2026

Zuerst gepostet (Tatsächlich)

23. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HPH-DED-SYS-2026-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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