Ocular effect of TRPM8 agonist in patients with dry eye disease
| ISRCTN | ISRCTN24802609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24802609 |
| Protocol serial number | N/A |
| Sponsor | Chonnam National University Medical School and Hospital |
| Funder | Investigator initiated and funded (South Korea) |
- 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
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
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
| Primary study design | Interventional |
|---|---|
| Study design | Single-center randomized double-masked vehicle-controlled study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 1-(Diisopropyl-phosphinoyl)-nonane |
| Primary outcome measure(s) |
1. Basal tear secretion (baseline and every 20 minutes) – assessed by Schirmer score |
| Key secondary outcome measure(s) |
1. Cooling sensation (baseline and every 5 minutes) – assessed by visual analogue scale (VAS) (0 to 10) |
| Completion date | 01/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| 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
Dong-gu
Gwangju
501-757
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| 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.
