An interventional study of smile exercise and 0.1% sodium hyaluronate eye drop in Dry Eye, Keratoconjunctivitis Sicca and Eye Diseases, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
The objective of the study is to evaluate the effectiveness of laughter therapy in relieving the symptoms of dry eye disease.
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.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 299 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
Compared within Keratoconjunctivitis Sicca, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dry Eye Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:.
Exclusion Criteria:
Contact lens wearing history:
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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
smile exercise, 4 times a day，8 weeks
Behavioral: smile exercise
0.1% sodium hyaluronate, 4 times a day, 8 weeks.
Drug: 0.1% sodium hyaluronate eye drop
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, 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.
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.
Time frame: 12 weeks
Proportion of Participants with 10 Points or More Decreased in OSDI
Proportion of participants with at least 10 points decreased from baseline in Ocular Surface Disease Index (OSDI).
Time frame: 12 weeks
Change from Baseline in Lipid layer thickness (LLT)
LLT from 1, 2, 4, 6, 8, 10 and 12 weeks minus values from baseline among eyes that qualified for the study. The interferometer LLT measurement is a non-invasively and objectively method that produces numeric value. The range of the value is 0-100+; lower value indicates thinner lipid layer.
Time frame: 12 weeks
Change in Non-invasive Tear film breakup time (NI-BUT)
In this measurement, NI-BUT is measured using the keratography machine. NI-BUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. Change is record as the values at 1, 2, 4, 6, 8, 10 and 12 weeks minus values at baseline visit. Possible range of score is 0-\>20. Lower values indicate greater severity.
Time frame: 12 weeks
Change in Tear Meniscus Height (TMH) by Keratography
Assessment of the tear film meniscus is a quantitative measurement of tear film quantity. In this measurement, TMH is measured using the keratography machine. Change is the values at 1, 2, 4, 6, 8, 10 and 12 weeks minus values at baseline visit.
Time frame: 12 weeks
Change in Corneal Fluorescein Staining Score
Corneal Flourescein Staining Score from 1, 2, 4, 6, 8, 10 and 12 weeks minus values from baseline visit among eyes that quality that qualified for the study. Possible range of scores is 0-15; higher scores indicate more severe.
Time frame: 12 weeks
Change in Self-Rating Anxiety Scale (SAS)
Medical Outcomes from study 20-Item Self-Rating Anxiety Scale. This scale range is 0-100 with lower scores indicating better self-reported mental health. Change is the score at 4, 8 and 12 weeks minus the score at baseline visit.
Time frame: 12 weeks
Change in Self-Rating Depression Scale (SDS)
Medical Outcomes from study 20--Item Self-Rating Depression Scale. This scale range is 0-100 with lower scores indicating better self-reported mental health. Change is the score at 4, 8 and 12 weeks minus the score at baseline visit.
Time frame: 12 weeks
Change in Subjective Happiness Scale
A 4-item scale designed to measure subjective happiness. Each of item is completed by choosing one of 7 options that finish a given sentence fragment. Change is the score at 4, 8 and 12 weeks minus the score at baseline visit.
Time frame: 12 weeks
Change in Pittsburgh Sleep Quality Index (PSQI)
Change is the score at 4, 8 and 12 weeks minus the score at the baseline visits. Scores for each question range from 0 to 3, and the total PSQI scores range from 0 to 100.
Time frame: 12 weeks
Change in SF-36 Physical Health Subscale
Medical Outcomes from study 36-Item Short Form Health Survey (SF-36) Physical Health Subscale. Subscale range is 0-100, with higher scores indicating better self-reported physical health-related quality of life. Change is the score at 4, 8 and 12 weeks minus the score at baseline visit.
Time frame: 12 weeks
Change in SF-36 Mental Health Subscale
Medical Outcomes from study 36-Item Short Form Health Survey (SF-36) Mental Health Subscale. Change is the score at 4, 8 and 12 weeks minus the score at baseline visit.
Time frame: 12 weeks
Change in Tear Cytokine Level
Change in levels of tear cytokines (mainly in inflammation cytokines, such as iL-17, TNF-alpha, etc.,). Change is the values from 8 and 12 weeks minus the the score at baseline visit.
Time frame: 12 weeks
Change in Lid Margin Abnormalities
Lid margin abnormalities were scored from 0 to 4 Change in lid margin abnormalities is the score from 4, 8 and 12 weeks minus the score at baseline visit.
Time frame: 12 weeks
Change in Meibum Quality
To evaluate meibum quality,five glands of the central part of the upper lid were assessed on a scale of 0-3 for each gland (total score range, 0-15).Change is the total score from 4, 8 and 12 weeks minus the score at baseline visit.
Time frame: 12 weeks
Change in Meibomian Gland Expressibility
The score of meibomian gland expressibility is range from 0-3. Change is the total score from 4, 8 and 12 weeks minus the score at baseline visit.
Time frame: 12 weeks
Change in Tear Film Break up Time, in Seconds (fluorescein staining)
Tear film break up time from1, 2, 4, 6, 8, 10 and 12 weeks minus values from baseline visit.
Time frame: 12 weeks
Change in Meibomian gland structure by Keratography
Change in Meibomian gland structure measured using the keratography machine. Change is the score from 8 and 12 weeks minus the values at baseline visit
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Apr 2021, 9 months.
Of 10 interventional studies with no phase under Keratoconjunctivitis Sicca, half reached primary completion within 7 months of starting (the median); a quarter within 2 and three quarters within 17. This study's 9 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhongshan Ophthalmic Center, Sun Yat-sen University →