Ocular effect of TRPM8 agonist in patients with dry eye disease

ISRCTN	ISRCTN24802609
DOI	https://doi.org/10.1186/ISRCTN24802609
Secondary identifying numbers	N/A

Submission date: 17/03/2015
Registration date: 21/03/2015
Last edited: 25/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Dry eye disease occurs when the eyes do not make enough tears or the tears evaporate too quickly, leading to the eyes drying out and becoming inflamed (red and swollen) and irritated. Our aim is to study the effect of topical administration of TRPM8 agonist in patients with mild to moderate dry eye disease.

Who can participate?
Patients with mild to moderate dry eye.

What does the study involve?
60 patients are randomly allocated to be treated with either TRPM8 agonist dissolved in distilled water, or distilled water only. Study medications will be topically applied twice on the upper eyelid. The severity of dry eye symptoms will be evaluated before and 1 hour after application.

What are the possible benefits and risks of participating?
There are no benefits and risks involved in this study.

Where is the study run from?
Department of Ophthalmology, Chonnam National University Medical School and Hospital (South Korea).

When is the study starting and how long is it expected to run for?
From January 2015 to March 2015.

Who is funding the study?
Investigator initiated and funded (South Korea).

Who is the main contact?
Pf. Kyung Chul Yoon
kcyoon@jnu.ac.kr

Contact information

Prof Kyung Chul Yoon
Scientific

Department of Ophthalmology
Chonnam National University Medical School and Hospital
42 Jebong-ro
Dong-gu
Gwangju
501-757
Korea, South

ORCID ID	0000-0002-2788-1851

Study information

Study design	Single-center randomized double-masked vehicle-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Effect of topical administration of TRPM8 agonist in patients with dry eye disease: a single-center randomized double-masked vehicle-controlled study
Study acronym	TRPM8 (transient receptor potential melastatin 8)
Study objectives	Topical administration of TRPM8 agonist may increase basal tear production in patients with mild to moderate dry eye disease. Also, it may provide short-term symptom relief of ocular dryness.
Ethics approval(s)	Institutional Review Board of Chonnam National University Hospital, 10/07/2014, IRB No. CNUH 2014-171
Health condition(s) or problem(s) studied	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.
Intervention	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 (50 mm x 60 mm), CS-being, Daisan Cotton, Japan) and wiped twice across the closed eyelid. A loading volume of 0.5 mL of solution on cotton was used to wet the cotton.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	1-(Diisopropyl-phosphinoyl)-nonane
Primary outcome measure	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 outcome measures	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)
Overall study start date	01/01/2015
Completion date	01/03/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60 patients (30 patients in each group)
Key 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
Key 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
Date of first enrolment	09/01/2015
Date of final enrolment	16/02/2015

Locations

Countries of recruitment

Korea, South

Study participating centre

Department of Ophthalmology, Chonnam National University Medical School and Hospital

42 Jebong-ro
Dong-gu
Gwangju
501-757
Korea, South

Sponsor information

Chonnam National University Medical School and Hospital
University/education

Department of Ophthalmology
42 Jebong-ro
Dong-gu
Gwangju
501-757
Korea, South

"ROR"	https://ror.org/00f200z37

Funders

Funder type

Other

Investigator initiated and funded (South Korea)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/06/2017	25/06/2020	Yes	No

Editorial Notes

25/06/2020: Publication reference added.