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

ISRCTN ISRCTN13359367
DOI https://doi.org/10.1186/ISRCTN13359367
Secondary identifying numbers N/A
Submission date
01/09/2015
Registration date
02/09/2015
Last edited
23/01/2019
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 daily topical administration of a drug called a 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?
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 to the upper eyelid 4 times daily (every 6 hours) for 2 weeks with using a stick filled with TRPM8 agonist or distilled water only.

What are the possible benefits and risks of participating?
The treatment may relieve dry eye related eye symptoms. There are no 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 August 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
Gwangju
KS0008
Korea, South

ORCiD logoORCID ID 0000-0002-2788-1851

Study information

Study designSingle-center randomized double-masked vehicle-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffect 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
Study objectivesDry 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. Daily topical administration of TRPM8 agonist may increase basal tear production in patients with mild to moderate dry eye disease. Also, it may provide symptom relief and improve patients quality of life related to ocular discomfort.
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) studiedDry eye
InterventionPatients 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 stick and topically applied in the margin of upper eyelid 4 times daily (every 6 hours) for 2 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)1-(Diisopropyl-phosphinoyl)-nonane
Primary outcome measure1. 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 outcome measures1. 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)
Overall study start date01/01/2015
Completion date31/08/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsAt least 40 patients (20 patients in each group)
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2015
Date of final enrolment01/08/2015

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Department of Ophthalmology
Chonnam National University Medical School and Hospital
KS0008
Korea, South

Sponsor information

Chonnam National University Medical School and Hospital
University/education

Department of Ophthalmology
42 Jebong-ro
Dong-gu
Gwangju
501-757
Gwangju
KS0008
Korea, South

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

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planTo 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 23/01/2019 Yes No
Results article results 15/11/2018 23/01/2019 Yes No

Editorial Notes

23/01/2019: Publication references added