Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease
2026년 7월 23일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
120
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Jalisco
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Zapopan, Jalisco, 멕시코
- Hospital Puerta de Hierro
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in tear break-up time (TBUT) from baseline to day 30
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Dalia Denisse Ng-Aleman, MD, Hospital Puerta de Hierro
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 1월 6일
기본 완료 (실제)
2025년 6월 30일
연구 완료 (실제)
2025년 6월 30일
연구 등록 날짜
최초 제출
2026년 7월 19일
QC 기준을 충족하는 최초 제출
2026년 7월 19일
처음 게시됨 (실제)
2026년 7월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HPH-DED-SYS-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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