Back to resultsA Randomized Study of Smile Exercise for Dry Eye
Primary Purpose
Dry Eye, Keratoconjunctivitis Sicca, Eye Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
smile exercise
0.1% sodium hyaluronate eye drop
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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.
Sites / Locations
- Zhonshan Ophthalmic Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
smile exercise
0.1% Sodium Hyaluronate Eye Drops
Arm Description
smile exercise, 4 times a day，8 weeks
0.1% sodium hyaluronate, 4 times a day, 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04421300
First Posted
June 1, 2020
Last Updated
July 22, 2020
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04421300
Brief Title
A Randomized Study of Smile Exercise for Dry Eye
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 patient by describing and evaluating a comprehensive set of features and treatment over 2 months of observation in a well-characterized group of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Keratoconjunctivitis Sicca, Eye Diseases, Corneal Diseases, Conjunctival Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
296 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
smile exercise
Arm Type
Experimental
Arm Description
smile exercise, 4 times a day，8 weeks
Arm Title
0.1% Sodium Hyaluronate Eye Drops
Arm Type
Active Comparator
Arm Description
0.1% sodium hyaluronate, 4 times a day, 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
smile exercise
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
0.1% sodium hyaluronate eye drop
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Ocular Surface Disease Index (OSDI) Score
Description
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
Secondary Outcome Measure Information:
Title
Proportion of Participants with 10 Points or More Decreased in OSDI
Description
Proportion of participants with at least 10 points decreased from baseline in Ocular Surface Disease Index (OSDI).
Time Frame
12 weeks
Title
Change from Baseline in Lipid layer thickness (LLT)
Description
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
Title
Change in Non-invasive Tear film breakup time (NI-BUT)
Description
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
Title
Change in Tear Meniscus Height (TMH) by Keratography
Description
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
Title
Change in Corneal Fluorescein Staining Score
Description
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
Title
Change in Self-Rating Anxiety Scale (SAS)
Description
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
Title
Change in Self-Rating Depression Scale (SDS)
Description
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
Title
Change in Subjective Happiness Scale
Description
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
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
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
Title
Change in SF-36 Physical Health Subscale
Description
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
Title
Change in SF-36 Mental Health Subscale
Description
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
Other Pre-specified Outcome Measures:
Title
Change in Tear Cytokine Level
Description
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
Title
Change in Lid Margin Abnormalities
Description
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
Title
Change in Meibum Quality
Description
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
Title
Change in Meibomian Gland Expressibility
Description
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
Title
Change in Tear Film Break up Time, in Seconds (fluorescein staining)
Description
Tear film break up time from1, 2, 4, 6, 8, 10 and 12 weeks minus values from baseline visit.
Time Frame
12 weeks
Title
Change in Meibomian gland structure by Keratography
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Zhonshan Ophthalmic Centre
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Study of Smile Exercise for Dry Eye
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