Ectopic activation of TRPM8 with a newly-developed agonist relieves dry-eye symptoms

Not Applicable

Completed

• Conditions: Dry eye; Eye Diseases; Other disorders of lacrimal gland

• Registration Number: ISRCTN13359367
• Lead Sponsor: Chonnam National University Medical School and Hospital

Brief Summary

1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28651550 (added 23/01/2019) 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30445735 (added 23/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-08-31
• Study Start: 2015-09-02
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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, 1 week, and 2 weeks follow-up) – assessed by Schirmer score<br> 2. Symptom score assessed by three questionnaires at baseline, 1 week, and 2 weeks follow-up:<br> 2.1. Visual analogue score (VAS)<br> 2.2. Ocular surface disease index (OSDI)<br> 2.3. Computer vision syndrome (CVS) related symptoms<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Tear-film break up time (baseline, 1 week, and 2 weeks follow-up) - the time before the defect of fluorescein dye appeared in the stained tear film was measured and recorded (measured TBUT 3 times and averaged)<br> 2. Keratoepitheliopathy score (baseline, 1 week, and 2 weeks follow-up) – after staining the cornea with fluorescein dye, the score was obtained by multiplying the stained area (0-3) by stained density (0-3)<br> Area (0, no punctate staining; 1, area occupied less than 1/3 of the cornea; 2, area occupied 1/3 to 2/3 of the cornea; 3, area occupied greater than 2/3 of the cornea)<br> Density (0, no punctate staining; 1, sparse density; 2, moderate density; 3, high density and the overlapped lesions)<br>