Clinical trial NCT04668118: The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
Official title: The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye Syndromes
Computer Vision Syndrome
Asthenopia
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of 3% Diquafosol Ophthalmic Solution for visual display terminal (VDT)-associated dry eye and to investigate the mechanism of treatment.

Detailed description: The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. The dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and the investigator will evaluate the symptoms and signs of Dry Eye.

Eligibility criteria: Inclusion Criteria:

* Male or female with a diagnosis dry eye based on Chinese Dry Eye Diagnosis Standard (2020)；
* Working in the offices with VDTs more than 4h daily；
* Working in the offices with VDTs at least five days per week；
* Provision of written informed consent.

Exclusion Criteria:

* Known allergy to any eye drops
* Ocular therapies other than artificial tears
* Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, contact lens wear, ocular surgical history, laser treatment in the last 3 months, Meibomian gland dysfunction (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
* Pregnant and lactating women, or those planning a pregnancy over the course of the study
* Uncontrolled systemic disease
* Hypersensitivity or intolerance to diquafosol(DQS)
* Subjects with a history of anxiety and depression

Primary outcomes:
measure: the changes of Ocular Surface Disease Index (OSDI) scores
timeFrame: 12 weeks after intervention
measure: the changes of Tear break-up time (TBUT)
timeFrame: 12 weeks after intervention
Secondary outcomes:
measure: the changes of scores of Corneal fluorescein staining (CFS)
timeFrame: 12 weeks after intervention
measure: the changes of scores of Lissamine green staining
timeFrame: 12 weeks after intervention
measure: the changes of value of Schirmer Ⅰ test (SⅠt)
timeFrame: 12 weeks after intervention
measure: the changes of Lipid layer thickness(LLT)
timeFrame: 12 weeks after intervention
measure: the changes of Partial blink rate(PBR)
timeFrame: 12 weeks after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Tingting Yang, MD
role: STUDY_DIRECTOR
References: