A Randomized Study of Smile Exercise for Dry Eye

NCT04421300 | Completed DMC

• 1 other identifier: 2020KYPJ010
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change of Ocular Surface Disease Index (OSDI) Score

  OSDI scores from 1, 2, 4, 6, 8, 10 and 12 weeks minus values from baseline. OSDI scores range from 0 to 100, score 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically significant change is 10 points.

  12 weeks

Secondary Outcomes (11)

• 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

Other Outcomes (6)

• Change in Tear Cytokine Level

  12 weeks

• Change in Lid Margin Abnormalities

  12 weeks

• Change in Meibum Quality

  12 weeks

Study Arms (2)

smile exercise

EXPERIMENTAL

smile exercise, 4 times a day，8 weeks

Behavioral: smile exercise

0.1% Sodium Hyaluronate Eye Drops

ACTIVE COMPARATOR

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

Drug: 0.1% sodium hyaluronate eye drop

Interventions

smile exercise 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

smile exercise

0.1% sodium hyaluronate eye drop 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.

0.1% Sodium Hyaluronate Eye Drops

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent approved by the Ethics Committee,
• to 45 years of age,
• 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.
• Best corrected visual acuity ≥10/20 in each eye
• Intraocular pressure (IOP) ≥5mmHg and≤21mmHg in each eye
• 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.
• Feasible for all visits and willing to follow instructions from the study investigator.

You may not qualify if:

• Corneal fluorescein staining present \>5 score.
• 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.
• Any corneal surgery within 12 months before Screening Visit .
• Participation in other medical studies 3 months before screening Visit.
• 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)
• Eyelid abnormalities that affect lid function (e.g. lagophthalmos, blepharospasm, ectropion, entropion, severe trichiasis, etc.)
• 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.)
• Currently diagnosis of glaucoma and under glaucoma medication or surgery treatment
• Currently using, or intent to have any specific treatments for dry eye disease
• Fluorescein sodium allergy
• Pregnant, nursing, or lactating
• Neurological or psychiatric disorders (moderate anxiety, depression and sleep disorders)

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhonshan Ophthalmic Centre

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 39260878 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Keratitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 9, 2020
• Study Start: July 2, 2020
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)