Status:
COMPLETED
Ditefossol Sodium 3% Eye Drops in Patients With Dry Eye
Lead Sponsor:
Tianjin Eye Hospital
Conditions:
Dry Eye Disease
Eligibility:
All Genders
23-75 years
Phase:
NA
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.
Detailed Description
1 ）Participants and Study Design This prospective clinical trial was conducted following ethical principles and received approval from the Ethics Committee of Tianjin Eye Hospital of China (Approval ...
Eligibility Criteria
Inclusion
- Inclusion criteria were based on the Chinese diagnostic criteria for DED16. Patients with DED were eligible if they met one of the following criteria:
- 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.
Exclusion
- Excluded were patients with allergies to any component of the drugs or diagnostic agents used; those who had used 3% diquafosol sodium eye drops within 2 weeks before enrollment; any systemic conditions affecting ocular medication; and corneal disorders preventing diagnostic tests, such as keratitis and corneal dystrophy. The exclusion criteria also included concurrent use of ocular or systemic NSAIDs, steroids, or immunosuppressants; recent use of eye drops; recent physical therapy or ocular surgery; recent contact lens wear; punctal plug treatment; independent ocular diseases requiring additional treatment; and pregnant or breastfeeding women or those planning to become pregnant. All female patients of childbearing age tested negative in a urine pregnancy test prior to enrollment. If both eyes met the inclusion criteria, the eye with the shorter FBUT was selected. If both eyes had the same FBUT, the right eye was selected.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2024
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT06560580
Start Date
November 15 2021
End Date
July 25 2024
Last Update
August 19 2024
Active Locations (1)
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1
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China