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 Diseases Other disorders of lacrimal gland
Conditions
Interventions
TRPM8 agonist (1-(Diisopropyl-phosphinoyl)-nonane) dissolved in distilled water (2 mg/mL) or vehicle (distilled water) was topically delivered using the absorbent cotton gauze square (0.4 g rectangle
Sponsors
Chonnam National University Medical School and Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Basal tear secretion (baseline and every 20 minutes) – assessed by Schirmer score 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cooling sensation (baseline and every 5 minutes) – assessed by visual analogue scale (VAS) (0 to 10) 2. Tear-film break up time (baseline and every 10 minutes) - the time before the defect of fluorescein dye appeared in the stained tear film was measured and recorded (measured TBUT 3 times and averaged) 3. Corneal sensitivity (baseline and every 20 minutes) – measured using the Cochet-Bonnet esthesiometer 4. Keratoepitheliopathy score (baseline and every 30 minutes) – after staining the cornea with fluorescein dye, the score was obtained by multiplying the stained area (0-3) by stained density (0-3) 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) Density (0, no punctate staining; 1, sparse density; 2, moderate density; 3, high density and the overlapped lesions) These outcomes were measured for 1 hour (60 minutes) | — |
Countries
Korea, South
Outcome results
None listed