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

Sponsors

Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Source Zhongshan Ophthalmic Center, Sun Yat-sen University
Brief 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.

Overall Status Enrolling by invitation
Start Date 2020-07-02
Completion Date 2021-03-30
Primary Completion Date 2020-12-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change of Ocular Surface Disease Index (OSDI) Score 12 weeks
Secondary Outcome
Measure Time Frame
Proportion of Participants with 10 Points or More Decreased in OSDI 12 weeks
Change from Baseline in Lipid layer thickness (LLT) 12 weeks
Change in Non-invasive Tear film breakup time (NI-BUT) 12 weeks
Change in Tear Meniscus Height (TMH) by Keratography 12 weeks
Change in Corneal Fluorescein Staining Score 12 weeks
Change in Self-Rating Anxiety Scale (SAS) 12 weeks
Change in Self-Rating Depression Scale (SDS) 12 weeks
Change in Subjective Happiness Scale 12 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) 12 weeks
Change in SF-36 Physical Health Subscale 12 weeks
Change in SF-36 Mental Health Subscale 12 weeks
Enrollment 296
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: smile exercise

Description: 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

Arm Group Label: smile exercise

Intervention Type: Drug

Intervention Name: 0.1% sodium hyaluronate eye drop

Description: 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.

Arm Group Label: 0.1% Sodium Hyaluronate Eye Drops

Eligibility

Criteria:

Inclusion Criteria: 1. Sign the informed consent approved by the Ethics Committee, 2. 18 to 45 years of age, 3. Meetting the dry eye diagnostic criteria of DEWs Ⅱ and demonstrating the following 2 condition in the same eye at screening and baseline visits (Same signs must present at both in Screening visit and Baseline visit). The same signs must be present in the same eye on both visits. The following parameters:. - Ocular Surface Disease Index (OSDI) score: 18-80 at and baseline visit. - Tear film break up time (TFBUT)<8s. 4. Best corrected visual acuity ≥10/20 in each eye 5. Intraocular pressure (IOP) ≥5mmHg and≤21mmHg in each eye 6. Women of child-bearing potential must agree to use a reliable method of contraception during study participation and must demonstrate a negative urine pregnancy test at the Screening Visit. 7. Feasible for all visits and willing to follow instructions from the study investigator. Exclusion Criteria: 1. Corneal fluorescein staining present >5 score. 2. Contact lens wearing history: - Used contact lenses within last 14 days prior to the Screening Visit. - Unwilling to avoid using contact lenses druing the study. 3. Any corneal surgery within 12 months before Screening Visit . 4. Participation in other medical studies 3 months before screening Visit. 5. Current or previous diagnosis of any following ocular conditions in 3 months: i). acute allergic conjunctivitis ii). infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids) iii). inflammation (e.g., retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis) 6. Eyelid abnormalities that affect lid function (e.g. lagophthalmos, blepharospasm, ectropion, entropion, severe trichiasis, etc.) 7. Extensive ocular surface scarring or condition that may compromise ocular surface integrity such as Stevens-Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects, prior ocular trauma, etc.) 8. Currently diagnosis of glaucoma and under glaucoma medication or surgery treatment 9. Currently using, or intent to have any specific treatments for dry eye disease 10. Fluorescein sodium allergy 11. Pregnant, nursing, or lactating 12. Neurological or psychiatric disorders (moderate anxiety, depression and sleep disorders) 13. Uncontrolled ocular or systemic diseases 14. History of epilepsy . 15. The researchers did not consider the patient is appropriate for inclusion in this study 16. Cognitive or psychiatric defect that precludes informed consent or ability to perform requirements in the investigation.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Location
Facility: Zhonshan Ophthalmic Centre
Location Countries

China

Verification Date

2020-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: smile exercise

Type: Experimental

Description: smile exercise, 4 times a day,8 weeks

Label: 0.1% Sodium Hyaluronate Eye Drops

Type: Active Comparator

Description: 0.1% sodium hyaluronate, 4 times a day, 8 weeks.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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