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

2026年7月23日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • メキシコ
    • Jalisco
      • Zapopan、Jalisco、メキシコ
        • Hospital Puerta de Hierro

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
他の名前：
  • Lipid-containing artificial tears
アクティブコンパレータ：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.
薬：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.
他の名前：
  • Hyaluronic acid and trehalose ophthalmic solution

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in tear break-up time (TBUT) from baseline to day 30
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Instituto Internacional de Medicina y Terapia (IIMET)

協力者

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

捜査官

  • 主任研究者：Dalia Denisse Ng-Aleman, MD、Hospital Puerta de Hierro

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年1月6日

一次修了 (実際)

2025年6月30日

研究の完了 (実際)

2025年6月30日

試験登録日

最初に提出

2026年7月19日

QC基準を満たした最初の提出物

2026年7月19日

最初の投稿 (実際)

2026年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月24日

QC基準を満たした最後の更新が送信されました

2026年7月23日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • HPH-DED-SYS-2026-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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