Ocular effect of TRPM8 agonist in patients with dry eye disease
Not Applicable
Completed
- Conditions
- Dry eye is a disorder of the tear film due to tear deficiency or excessive evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort.Eye DiseasesOther disorders of lacrimal gland
- Registration Number
- ISRCTN24802609
- Lead Sponsor
- Chonnam National University Medical School and Hospital
- Brief Summary
2017 results in https://pubmed.ncbi.nlm.nih.gov/28651550/ (added 25/06/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Dry eye symptoms for more than 3 months despite the use of artificial tears
2. Low tear film break-up time (TBUT) (= 7 seconds)
3. Low Schirmer score (= 10 mm/5 min)
4. Presence of corneal and conjunctival epithelial damage
Exclusion Criteria
1. History of any ocular disease other than DED
2. Meibomian gland dysfunction
3. Contact lens use
4. Ocular trauma or surgeries
5. Presence of an uncontrolled systemic disease that could affect ocular surface condition
6. Punctual plugs
7. Used any eye drops other than artificial tears
8. Used any systemic medication that can cause dry eye
9. Pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Basal tear secretion (baseline and every 20 minutes) – assessed by Schirmer score<br> 2. Dry eye symptom (baseline and after 60 minutes): using the questionnaire (0, no symptoms; 1, mild symptoms; 2, moderate symptoms; 3, severe symptoms; and 4, very severe symptoms)<br>
- Secondary Outcome Measures
Name Time Method