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

Effect of daily topical administration of TRPM8 agonist in patients with mild to moderate dry eye disease: a single-center randomized double-masked vehicle-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13359367

Enrollment

Registered

2015-09-02

Start date

2015-07-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye Eye Diseases Other disorders of lacrimal gland

Interventions

Patients will be randomized to be treated with TRPM8 agonist (1-(Diisopropyl-phosphinoyl)-nonane) dissolved in distilled water (2 mg/mL) or vehicle (distilled water) topically delivered using the stic

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

Secondary

Measure	Time frame
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) 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) 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)	—

Measure

Time frame

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) 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) 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)

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Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026