A Comparative Exploration Clinical Study to evaluate the Effect of Drying Eye Disease by Using LED
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0004608
- Lead Sponsor
- Dankook Univeristy Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1) Adults and women aged 19 or older
2) Those who meet at least one of the following criteria from at least one of the two eyes
A. Oxford Grading for Fluorescent Dyeing Scores of the Subjects with Corneal Inflammation
B. The person which is 10mm / 5min or less in the tear quantity test (Schimmer test) under the non-anesthesia at the screening time
The person in which the C. TBUT (Tear film break-up time) check result is 10 second or less
3) The person having the dry eye symptom [dryness, the discomfort (discomfort), the foreign body sensation, the pain, the vision fluctuation etc] it is diagnosed in the screening point of time as the dry eye syndrome
4) Those who agreed not to use eye drops other than artificial leakage provided by this clinical trial during the clinical trial
5) Those who can understand this clinical trial and voluntarily agree to it
1) Adults and women aged 19 or older
2) Those who meet at least one of the following criteria from at least one of the two eyes
A. Oxford Grading for Fluorescent Dyeing Scores of the Subjects with Corneal Inflammation
B. The person which is 10mm / 5min or less in the tear quantity test (Schimmer test) under the non-anesthesia at the screening time
The person in which the C. TBUT (Tear film break-up time) check result is 10 second or less
3) The person having the dry eye symptom [dryness, the discomfort (discomfort), the foreign body sensation, the pain, the vision fluctuation etc] it is diagnosed in the screening point of time as the dry eye syndrome
4) Those who agreed not to use eye drops other than artificial leakage provided by this clinical trial during the clinical trial
5) Those who can understand this clinical trial and voluntarily agree to it
6) The person having the active ocular infection symptom including the anterior uveitis, the anterior ophthalmitis, the Steven-Johnson syndrome etc
7) If you have eye allergies or are currently being treated for allergic eye diseases (such as the use of antihistamines)
8) Patients with autoimmune disease (e.g., Sjögren's syndrome, Rheumatoid arthritis, systemic lupus erythematosus, Graves' disease, etc.)
9) The person who needs surgery due to the surface elevation by the Meibomian Gland Dysfunction (MGD)
10) The person with the past history of corneal transplantation or the neurotrophic keratitis
11) The person in which the intraocular pressure is 25mmHg or greater among both eyes or which is diagnosed as glaucoma
12) Those who underwent vision correction surgery such as LASIK (Laser-Assisted in Situ Keratomiileus) within 12 months before screening
13) Those who received silicone lacrimal punctal occlusion or cauterization of the punctum within 90 days before screening.,However, collagen tear point closure (collag)
14) Pregnant women or nursing women
15) a potential for drug or alcohol abuse
16) Those who are inappropriate to participate in clinical trials under the judgment of the tester
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular surface disease index (OSDI) score;Changes in the Fluorescein Corneal Staining Score - Oxford Grading
- Secondary Outcome Measures
Name Time Method Changes in the Conjunctival Staining Score of Lissamine Green Conjunctival - Oxford Grading;Changes in the Schimmer Test;Changes in Tear Film Break-up Time (TBUT);Changes in Invasive or Noninvasive, Expressible Meibomian lands and Quality;Safety assessment (monitoring of adverse reactions such as awareness and other symptoms, adverse reactions identified in microscopic examinations such as eye examinations and microscopy)