Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management
Dry Eye Syndromes
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 60 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 30 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The goal of this pilot clinical study is to learn if Lycium barbarum polysaccharide (LBP) supplementation helps manage dry eye disease in adults. It will also learn about the safety of LBP supplementation.
The main questions it aims to answer are:
1. Does LBP supplementation improve dry eye symptoms after 12 weeks?
2. Does LBP supplementation improve clinical signs of dry eye disease, such as tear film stability, tear production, and ocular surface staining?
Researchers will evaluate changes in dry eye symptoms and eye examination results before and after LBP supplementation.
Participants will:
1. Take LBP tablets by mouth twice daily for 12 weeks
2. Visit the clinic at baseline, 4 weeks, and 12 weeks for checkups and eye tests
3. Complete dry eye questionnaires and undergo clinical assessments of tear film, ocular surface health, and related eye measurements
Leer la descripción completa
Dry eye disease is associated with disruption of tear film homeostasis, ocular surface inflammation, and ocular discomfort. Current management often includes lubricating eye drops and other supportive approaches, but additional interventions that may support ocular surface health remain of interest.
Lycium barbarum polysaccharide is a bioactive component derived from goji berry. Previous laboratory and animal studies suggest that it may have antioxidant, anti-inflammatory, and neuroprotective effects relevant to ocular surface disease. However, clinical data on its use in people with dry eye disease are limited.
This pilot study will generate preliminary clinical information on oral Lycium barbarum polysaccharide supplementation in adults with dry eye disease. The study will use standardized optometric assessments in a clinical research setting to characterize changes in dry eye-related symptoms and ocular surface findings over the study period.
Information from this pilot study may help determine whether further investigation of Lycium barbarum polysaccharide supplementation in dry eye disease is warranted in a larger controlled trial.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Age 18 to 60 years at enrollment.
- Clinical diagnosis of dry eye disease, defined as OSDI-12 score \>=13 and at least one clinical sign of dry eye disease.
- Habitual visual acuity 6/9 or better in both eyes.
- Able to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Ocular infection within 3 months before enrollment or ocular disease other than dry eye disease.
- History of ocular surgery, including refractive surgery.
- Use of dry eye-related products, such as artificial tears, within 1 month before enrollment.
- Contact lens wear within 1 month before enrollment.
- Long-term use of medications known to affect dry eye symptoms.
- Severe or unstable systemic disease.
- Infectious disease, such as viral influenza.
- Known allergy or hypersensitivity to Lycium barbarum polysaccharide.
- Pregnant or breastfeeding.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Lycium Barbarum Polysaccharide Supplementation
Participants will receive oral Lycium barbarum polysaccharide supplementation for 12 weeks.
Dietary Supplement: Lycium Barbarum Polysaccharide
Lycium Barbarum Polysaccharide DIETARY_SUPPLEMENT
Participants will take Lycium barbarum polysaccharide tablets orally for 12 weeks. The dosing regimen is two tablets twice daily, for a total of four tablets per day. Each tablet contains Lycium barbarum glycoconjugates, blueberry powder, and grape seed extract.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in 12-Item Ocular Surface Disease Index Score
Plazo: Baseline and Week 12
The 12-item Ocular Surface Disease Index (OSDI-12) assesses dry eye symptoms. Scores range from 0 to 100, with higher scores indicating worse symptoms. Change from baseline to Week 12 will be assessed.
Medidas secundarias
Change in First Non-Invasive Tear Break-Up Time
Plazo: Baseline and Week 12
First non-invasive tear break-up time will be measured in seconds using the Oculus Keratograph 5M. Longer times indicate greater tear film stability. Change from baseline to Week 12 will be assessed.
Change in Tear Film Lipid Layer Thickness
Plazo: Baseline and Week 12
Tear film lipid layer thickness will be measured in nanometers using the IDRA Ocular Surface Analyzer. Change from baseline to Week 12 will be assessed.
Change in Tear Meniscus Height
Plazo: Baseline and Week 12
Lower tear meniscus height will be measured in millimeters using the Oculus Keratograph 5M. Change from baseline to Week 12 will be assessed.
Change in Corneal Sensitivity Threshold
Plazo: Baseline and Week 12
Corneal sensitivity threshold will be measured in millibars using the Brill non-contact corneal esthesiometer. Lower thresholds indicate greater corneal sensitivity. Change from baseline to Week 12 will be assessed.
Change in Schirmer Test Wetting Length
Plazo: Baseline and Week 12
Tear production will be assessed using the Schirmer test, with strip wetting length recorded in millimeters after 5 minutes. Greater wetting length indicates greater tear production. Change from baseline to Week 12 will be assessed.
Change in Visual Acuity
Plazo: Baseline and Week 12
Monocular visual acuity will be measured using a standard visual acuity chart and recorded as a Snellen fraction. Follow-up testing will use the baseline objective refraction, where available; otherwise, habitual visual acuity will be used. Change from baseline to Week 12 will be assessed.
Change in National Eye Institute Corneal Fluorescein Staining Score
Plazo: Baseline and Week 12
Corneal fluorescein staining will be graded using the National Eye Institute scale, with total scores ranging from 0 to 15 per eye. Higher scores indicate more severe staining. Change from baseline to Week 12 will be assessed.
Change in National Eye Institute Conjunctival Lissamine Green Staining Score
Plazo: Baseline and Week 12
Conjunctival lissamine green staining will be graded using the National Eye Institute scale, with total scores ranging from 0 to 18 per eye. Higher scores indicate more severe staining. Change from baseline to Week 12 will be assessed.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
The Hong Kong Polytechnic University, School of Optometry, Optometry ClinicHong Kong, Hong Kong, Hong KongReclutando
Equipo y fechas
- Patrocinador principal
- The Hong Kong Polytechnic University
- Inicio del estudio
- 14 sept 2026 Real
- Finalización primaria
- 1 ene 2027 Estimado
- Finalización del estudio
- 1 ago 2027 Estimado
- Primera publicación
- 25 sept 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management : A Pilot Study
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026