Ditefossol Sodium 3% Eye Drops in Patients With Dry Eye

NCT06560580 | Completed

• 1 other identifier: zhangyi2024
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease

Keywords

diquafosol sodium; age groups; propensity score matching; longitudinal study; dry eye disease

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Intraocular Pressure (IOP):

  Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.

Study Arms (2)

Older group

OTHER

Patients were divided into two groups based on age: the younger group (\<40 years) and the older group (≥40 years). PSM (1:1) was used to ensure no significant differences in baseline characteristics between the two groups

Drug: 3% Diquafosol Sodium Eye Drops

Younger group

OTHER

Patients were divided into two groups based on age: the younger group (\<40 years) and the older group (≥40 years). PSM (1:1) was used to ensure no significant differences in baseline characteristics between the two groups

Drug: 3% Diquafosol Sodium Eye Drops

Interventions

3% Diquafosol Sodium Eye Drops DRUG

Each patient was prescribed 3% (5 mL: 150 mg) diquafosol sodium eye drops \[Diquas®, provided by Santen Pharmaceutical (China) Co., Ltd.\], recommended to instill one drop six times daily for 3 months. Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.

Older group; Younger group

Eligibility Criteria

• Age: 23 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They reported symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, redness, or fluctuating vision, with a Chinese dry eye questionnaire score (DEQS) ≥7. Additionally, they had either a fluorescein tear breakup time (FBUT) ≤5 s, a non-invasive tear breakup time (NIBUT) \<10 s, or a Schirmer I test (without anesthesia) ≤5 mm/5 min.
• They had dry eye-related symptoms with a Chinese DEQS ≥7. Additionally, they had either FBUT \>5 s and ≤10 s, NIBUT between 10 and 12 s, or a Schirmer I test (without anesthesia) \>5 mm/5 min and ≤10 mm/5 min. Furthermore, patients were required to have positive fluorescein staining (≥5 spots) for diagnosis.

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Yi Zhang

  Tianjin Eye Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: November 15, 2021
• Primary Completion: July 20, 2023
• Study Completion: July 25, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CN (1)