Ditefossol Sodium 3% Eye Drops in Patients With Dry Eye
NCT Number: NCT06560580
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Eye Disease
Interventions: DRUG: 3% Diquafosol Sodium Eye Drops
Sponsor: Tianjin Eye Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 97
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-15
Completion Date: 2024-07-25
Locations: Tianjin Eye Hospital, Tianjin, Tianjin, China

Summary:
This study aimed to evaluate the efficacy of 3% diquafosol sodium eye drops in treating dry eye disease (DED) across different age groups using a propensity score-matched longitudinal design.

Primary Outcome Measures: Dry Eye Questionnaire Score (DEQS), DEQS was administered first to assess the subjective symptoms of dry eye. Patients were asked to complete a questionnaire that included multiple items evaluating discomfort and the impact of dry eyes on daily life. The scores were calculated using a standardized DEQS scoring system., Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.|Visual Acuity (VA):, VA was measured using a 5 m standard Snellen chart and recorded in decimal notation. VA was then converted to the Logarithm of the Minimum Angle of Resolution (LogMAR) format for statistical analysis., Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.|Lipid Layer Thickness:, The lipid layer thickness was evaluated using a LipiView interferometer based on the principle of white-light interference., Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.|Tear Meniscus Height (TMH):, TMH was measured using an ocular surface analyzer. This device captured images of the tear meniscus at the lower eyelid margin to assess tear volume., Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.|Meibomian Gland Dropout Area (MGDA):, MGDA was examined using an ocular surface analyzer (Oculus, Wetzlar, Germany). Infrared imaging was employed to visualize the meibomian glands in the eyelids, and the extent of gland dropout was quantified using the ImageJ software version 1.54j (National Institute of Health, Bethesda, MD, USA)., Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.|Fluorescein Tear Breakup Time (FBUT):, FBUT was measured by instilling a fluorescein dye into the conjunctival sac and instructing the patient to blink several times to spread the dye uniformly. The time from the last blink to the first appearance of a dry spot on the corneal surface was recorded using a slit-lamp biomicroscope (Nidek. Gamagori, Japan) with a cobalt blue light. The test was performed thrice for each eye, and the average time was calculated., Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.|Schirmer I Test:, Schirmer I test was performed without anesthesia. Standardized Schirmer strips were placed at the junction of the middle and lateral thirds of the lower eyelid margins for 5 min. Wetting length on the strip was measured in millimeters to assess basal and reflex tear production. This test was performed at least 30 min after the FBUT test to prevent interference., Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.
Secondary Outcome Measures: Intraocular Pressure (IOP):, IOP was measured using a non-contact tonometer (Suoer, Zhongshan, China). The device delivered a puff of air to the cornea, and the resistance was used to calculate the IOP. Three measurements were taken for each eye and the average IOP was recorded., Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.