Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease
23. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Jalisco
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Zapopan, Jalisco, Mexico
- Hospital Puerta de Hierro
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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.
Andre navn:
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Aktiv 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.
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
Tidsramme: From baseline (day 0) to day 30 of treatment
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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.
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From baseline (day 0) to day 30 of treatment
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in tear break-up time (TBUT) from baseline to day 30
Tidsramme: Baseline and day 30 after start of treatment
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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.
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Baseline and day 30 after start of treatment
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Change in Schirmer test value from baseline to day 30
Tidsramme: Baseline and day 30 after start of treatment
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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.
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Baseline and day 30 after start of treatment
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Treatment adherence over 30 days of follow-up
Tidsramme: Day 15 and day 30 of treatment
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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.
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Day 15 and day 30 of treatment
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Change in Oxford corneal and conjunctival staining score from baseline to day 30
Tidsramme: Baseline and day 30 after start of treatment
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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.
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Baseline and day 30 after start of treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Dalia Denisse Ng-Aleman, MD, Hospital Puerta de Hierro
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. januar 2025
Primær fullføring (Faktiske)
30. juni 2025
Studiet fullført (Faktiske)
30. juni 2025
Datoer for studieregistrering
Først innsendt
19. juli 2026
Først innsendt som oppfylte QC-kriteriene
19. juli 2026
Først lagt ut (Faktiske)
23. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HPH-DED-SYS-2026-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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