A Randomized Study of Smile Exercise for Dry Eye

NCT ID: NCT04421300

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-02
• Study Completion Date: 2021-04-02

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.

Conditions

Dry Eye; Keratoconjunctivitis Sicca; Eye Diseases; Corneal Diseases; Conjunctival Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

smile exercise

smile exercise, 4 times a day，8 weeks

Group Type: EXPERIMENTAL

smile exercise

Intervention Type: BEHAVIORAL

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

0.1% Sodium Hyaluronate Eye Drops

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

Group Type: ACTIVE_COMPARATOR

0.1% sodium hyaluronate eye drop

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhonshan Ophthalmic Centre

Guangzhou, Guangdong, China

Countries

China

References

Li J, Liao Y, Zhang SY, Jin L, Congdon N, Fan Z, Zeng Y, Zheng Y, Liu Z, Liu Y, Liang L. Effect of laughter exercise versus 0.1% sodium hyaluronic acid on ocular surface discomfort in dry eye disease: non-inferiority randomised controlled trial. BMJ. 2024 Sep 11;386:e080474. doi: 10.1136/bmj-2024-080474.

Reference Type: DERIVED

PMID: 39260878 (View on PubMed)

Other Identifiers

2020KYPJ010

Identifier Type: -

Identifier Source: org_study_id