Safety and Effectiveness of EyePeace on Signs and Symptoms of Dry Eye Disease

Study Overview
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Brief Summary
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In this study, the EyePeace an eye massager will be compared with a standard-of-care warm compress treatment with evaporative dry eye disease. The objective is to asses the safety and effectiveness EyePeace eye massager is in relieving the signs and symptoms of evaporative dry eye disease.

Detailed Description
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A prospective, contralateral-eye trial study compared the effects of Eyepeace+Heated eye mask versus Heated eye mask with dry eye patients. Following 10 min of heated eye mask on both eyes, eyelid massage therapy was applied to the right eye by device. The efficiency was evaluated at baseline (0 mins), 5 minutes (5 mins), 15 minutes (15 mins), and 30 minutes (30 mins) by having the patient perform the eyelid expression massage under the supervision of an ophthalmologist. Non-invasive breakup time (NITBUT), tear meniscus height (TMH), tear-film lipid layer (TFLL), ocular surface temperature (OST), meibomian gland quality (MGQ), meibomian gland expressibility (MGEx), best corrected visual acuity (BCVA), intraocular pressure (IOP), endothelial cell count (ECC), flat-axis keratometry value (K1), steep-axis keratometry value (K2), and central corneal thickness (CCT) were examined.

Official Title
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Safety and Effectiveness of EyePeace on Signs and Symptoms of Dry Eye Disease

Conditions
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Evaporative Dry Eye

Intervention / Treatment
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* Device: EyePeace
* Device: Heated Eye Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Able and willing to comply with the treatment/follow-up schedule Bilateral signs and symptoms of dry eye disease or MGD Exclusion Criteria: Treat dry eye with medication or massage or fumigation within 1 month The eyelids or intraocular tumor unfavorable pressure Previous ocular surgery or trauma Barriers to the subjects in the research of ocular surface active allergies, infection or inflammatory bowel disease Intraocular pressure is less than 10 mmHg or more than 21 mmHg Diabetes or other eye table, healthy body, skin diseases, or diseases of the nervous system; Use any may interfere with tears within three months of systemic anti-inflammatory drugs or medicines, such as resistance to anxiety, depression and antihistamines The local administration of ophthalmology recent history (in the past 30 days) including antibiotics, steroids and non-steroidal anti-inflammatory drug, or long-term use of local ophthalmic drug Researchers determine patients not suitable for this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, comparative pilot study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EyePeace+Heated eye mask group<br>Participants will received the HEM therapy for 10 minutes according to the manufacturer's instructions. This was followed immediately by 10 gentle squeezes of the eyelid massage device on one eye | Device: EyePeace<br>* EyePeace a commercially available for enhancing meibum expression. The flexible, handheld device is made of silicone and provides regulated vertical pressure on closed eyelids (https://www.eyepeace.de). EyePeace will be used to assess its usefulness in improving evaporative dry eye signs and symptoms.<br>* Other names: Eye massager;Device: Heated Eye Mask<br>* Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.<br>* Other names: HEM;|
| Active Comparator: Heated Eye Mask group<br>Participants in Heated Eye Mask group will use heated eye mask once. | Device: Heated Eye Mask<br>* Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.<br>* Other names: HEM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive tear break-up time | Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded. | Baseline, 5 min, 15 min, 30 min | 
| Tear Film Lipid Layer | Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). | Baseline, 30 min | 
| Expressibility of meibum grade | Meibum expressibility will be assessed under a slit-lamp: Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible; 1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands. | Baseline, 5 min, 15 min, 30 min | 
| Quality of meibum grade | Meibum quality will be assessed under a slit-lamp: Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum). | Baseline, 5 min, 15 min, 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival hyperemia (RS score) | Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0. | Baseline, 5 min, 15 min, 30 min | 
| Conjunctivocorneal epithelial staining grade | Conjunctivocorneal epithelial staining will be assessed under a slit-lamp: Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac. The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (severe). | Baseline, 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Eye massage, Diquafosol, Eyepeace