Status:
COMPLETED
A Randomized Study of Smile Exercise for Dry Eye
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions:
Dry Eye
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18-45 years
Phase:
NA
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2021
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT04421300
Start Date
July 2 2020
End Date
April 2 2021
Last Update
May 14 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhonshan Ophthalmic Centre
Guangzhou, Guangdong, China, 510000