NCT04421300

A Randomized Study of Smile Exercise for Dry Eye

Clinical Efficacy of Smile Exercise Versus 0.1% Hyaluronic Acid Sodium Eye Drops for Dry Eye Symptoms in Patients With Dry Eye Disease: a Randomized, Controlled, Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to evaluate the effectiveness of laughter therapy in relieving the symptoms of dry eye disease.

Detailed description

The study is designed to: Test the hypothesis that smile exercise is an effective treatment for Dry Eye Disease (DED) . Better understand the status of emotion, quality of sleep and life in DED patient by describing and evaluating a comprehensive set of features and treatment over 2 months of observation in a well-characterized group of patients.

Conditions

• Dry Eye
• Keratoconjunctivitis Sicca
• Eye Diseases
• Corneal Diseases
• Conjunctival Diseases

Interventions

Type	Name	Description
BEHAVIORAL	smile exercise	Launch the "smile face recognition" APP on smart phone, after user guidance and pretest, a smile exercise will display on the phone, while facing the front camera on the phone, participant will do an exercise emphasizing facial movements, as exaggerated as possible. The exercise last for 8 weeks and 4 times a day
DRUG	0.1% sodium hyaluronate eye drop	0.1% sodium hyaluronate, 4 times a day, the time is in the morning, lunchtime, afternoon and evening. the interval between two training time is 2 hours, 1 hour before and after can be added or subtracted by users, 8 weeks.

Timeline

• Start date: 2020-07-02
• Primary completion: 2021-04-02
• Completion: 2021-04-02
• First posted: 2020-06-09
• Last updated: 2024-05-14

Locations

1 site across 1 country: China