A Randomized Study of Smile Exercise for Dry Eye

Sun Yat-sen University

Status

Completed

Conditions

Conjunctival Diseases

Dry Eye

Corneal Diseases

Eye Diseases

Keratoconjunctivitis Sicca

Treatments

Behavioral: smile exercise

Drug: 0.1% sodium hyaluronate eye drop

Study type

Interventional

Funder types

Other

Identifiers

NCT04421300

2020KYPJ010

Details and patient eligibility

About

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

Full 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.

Enrollment

299 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Sign the informed consent approved by the Ethics Committee,
18 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.

Exclusion criteria

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)
Uncontrolled ocular or systemic diseases
History of epilepsy .
The researchers did not consider the patient is appropriate for inclusion in this study
Cognitive or psychiatric defect that precludes informed consent or ability to perform requirements in the investigation.