Dry EyeNCT04421300
A Randomized Study of Smile Exercise for Dry Eye
A study testing smile exercise and 0.1% sodium hyaluronate eye drop in people with Dry Eye and Keratoconjunctivitis Sicca, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The objective of the study is to evaluate the effectiveness of laughter therapy in relieving the symptoms of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Keratoconjunctivitis Sicca, Eye Diseases
- What is being tested?
- smile exercise and 0.1% sodium hyaluronate eye drop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2020to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Smile Exercise Versus 0.1% Hyaluronic Acid Sodium Eye Drops for Dry Eye Symptoms in Patients With Dry Eye Disease: a Randomized, Controlled, Non-inferiority Trial
The objective of the study is to evaluate the effectiveness of laughter therapy in relieving the symptoms of dry eye disease.
Read the 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
- Being tested
- smile exercise, 0.1% sodium hyaluronate eye drop
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, Eye Diseases, Corneal Diseases, Conjunctival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smile exerciseBehavioural
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 dropDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| smile exercise | Experimental | smile exercise, 4 times a day，8 weeks Receives: Behavioral: smile exercise |
| 0.1% Sodium Hyaluronate Eye Drops | Active comparator | 0.1% sodium hyaluronate, 4 times a day, 8 weeks. Receives: Drug: 0.1% sodium hyaluronate eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start2 Jul 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421300
- Sponsor's protocol ID
- 2020KYPJ010
- Status last verified
- May 2024
- First submitted
- 1 Jun 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39260878
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Smile Exercise Versus 0.1% Hyaluronic Acid Sodium Eye Drops for Dry Eye Symptoms in Patients With Dry Eye Disease: a Randomized, Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04421300
- Acronym / sponsor ID
- 2020KYPJ010
- Conditions
- Dry Eye, Keratoconjunctivitis Sicca, Eye Diseases, Corneal Diseases, Conjunctival Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smile exercise | Experimental | Behavioral: smile exercisesmile exercise, 4 times a day，8 weeks |
| 0.1% Sodium Hyaluronate Eye Drops | Active comparator | Drug: 0.1% sodium hyaluronate eye drop0.1% sodium hyaluronate, 4 times a day, 8 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:.
- Best corrected visual acuity ≥10/20 in each eye
- Intraocular pressure (IOP) ≥5mmHg and≤21mmHg in each eye
Key exclusion criteria (19 listed)
- Corneal fluorescein staining present >5 score.
- Contact lens wearing history:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smile exerciseLaunch 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 | Behavioural | smile exercise |
| 0.1% sodium hyaluronate eye drop0.1% 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. | Drug | 0.1% Sodium Hyaluronate Eye Drops |
Primary outcome
Change of Ocular Surface Disease Index (OSDI) Score
Time frame: 12 weeks
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.
11 secondary outcomes
Proportion of Participants with 10 Points or More Decreased in OSDI
Time frame: 12 weeks
Change from Baseline in Lipid layer thickness (LLT)
Time frame: 12 weeks
Change in Non-invasive Tear film breakup time (NI-BUT)
Time frame: 12 weeks
Change in Tear Meniscus Height (TMH) by Keratography
Time frame: 12 weeks
Change in Corneal Fluorescein Staining Score
Time frame: 12 weeks
Change in Self-Rating Anxiety Scale (SAS)
Time frame: 12 weeks
Change in Self-Rating Depression Scale (SDS)
Time frame: 12 weeks
Change in Subjective Happiness Scale
Time frame: 12 weeks
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks
Change in SF-36 Physical Health Subscale
Time frame: 12 weeks
Change in SF-36 Mental Health Subscale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 39260878Li 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.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 4
Cooling Eyedrops for Dry Eye
Dry Eye
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smile exercise and 0.1% sodium hyaluronate eye drop in people with Dry Eye and Keratoconjunctivitis Sicca, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Ocular Surface Disease Index (OSDI) Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.