Evaporative Dry Eye Clinical Trial
Official title:
Safety and Effectiveness of EyePeace on Signs and Symptoms of Dry Eye Disease
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | April 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | He Eye Hospital | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
He Eye Hospital |
China,
Butovich IA. Lipidomics of human Meibomian gland secretions: Chemistry, biophysics, and physiological role of Meibomian lipids. Prog Lipid Res. 2011 Jul;50(3):278-301. doi: 10.1016/j.plipres.2011.03.003. Epub 2011 Mar 31. — View Citation
Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20. — View Citation
Heidari M, Noorizadeh F, Wu K, Inomata T, Mashaghi A. Dry Eye Disease: Emerging Approaches to Disease Analysis and Therapy. J Clin Med. 2019 Sep 11;8(9):1439. doi: 10.3390/jcm8091439. — View Citation
Ma J, Pazo EE, Zou Z, Jin F. Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: A cross-sectional study. Breast. 2020 Oct;53:164-171. doi: 10.1016/j.breast.2020.07.009. Epub 2020 Aug 5. — View Citation
McMonnies CW. Management of chronic habits of abnormal eye rubbing. Cont Lens Anterior Eye. 2008 Apr;31(2):95-102. doi: 10.1016/j.clae.2007.07.008. Epub 2008 Mar 19. — View Citation
Olson MC, Korb DR, Greiner JV. Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Eye Contact Lens. 2003 Apr;29(2):96-9. doi: 10.1097/01.ICL.0000060998.20142.8D. — View Citation
Tichenor AA, Cox SM, Ziemanski JF, Ngo W, Karpecki PM, Nichols KK, Nichols JJ. Effect of the Bruder moist heat eye compress on contact lens discomfort in contact lens wearers: An open-label randomized clinical trial. Cont Lens Anterior Eye. 2019 Dec;42(6):625-632. doi: 10.1016/j.clae.2019.09.005. Epub 2019 Oct 3. — View Citation
Wang MTM, Feng J, Wong J, Turnbull PR, Craig JP. Randomised trial of the clinical utility of an eyelid massage device for the management of meibomian gland dysfunction. Cont Lens Anterior Eye. 2019 Dec;42(6):620-624. doi: 10.1016/j.clae.2019.07.008. Epub 2019 Jul 26. — View Citation
Zhang Q, Wu Y, Song Y, Qin G, Yang L, Talwar SS, Lin T, Talwar GDS, Zhang H, Xu L, Moore JE, Pazo EE, He W. Screening Evaporative Dry Eyes Severity Using an Infrared Image. J Ophthalmol. 2021 Aug 24;2021:8396503. doi: 10.1155/2021/8396503. eCollection 2021. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Tear Film Lipid Layer | Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). | Baseline, 30 min | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT04091581 -
Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye
|
Phase 4 | |
Active, not recruiting |
NCT04608942 -
Refractory Meibomian Gland Dysfunction and Plasma Jet
|
N/A | |
Completed |
NCT03055897 -
Tear Film Innovations iLux Safety Study
|
N/A | |
Completed |
NCT05536661 -
Impact of Tear Substitute Use on Dry Eye in Gamers.
|
N/A | |
Completed |
NCT04658927 -
Dextenza With ILUX for Treatment of MGD
|
Phase 4 | |
Not yet recruiting |
NCT04711642 -
Comprehensive Study on Dry Eye and Ocular Surface Disease Prior and After Cataract Surgery
|
Phase 3 | |
Completed |
NCT03055650 -
iLux Treatment for Meibomian Gland Dysfunction (MGD)
|
N/A | |
Completed |
NCT05331924 -
Quality of Life Improvement in Dry Eye Patients After Intense Pulsed Light Therapy Compared to Punctal Plugs
|
N/A | |
Completed |
NCT04037969 -
Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
|
N/A |