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
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
Scientific
Department of Ophthalmology
Chonnam National University Medical School and Hospital
42 Jebong-ro
Dong-gu
Gwangju
501-757
Gwangju
KS0008
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 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 objectives | 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. 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) studied | Dry eye |
| Intervention | 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 stick and topically applied in the margin of upper eyelid 4 times daily (every 6 hours) for 2 weeks. |
| 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, 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 measures | 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) |
| Overall study start date | 01/01/2015 |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | At least 40 patients (20 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 | 01/07/2015 |
| Date of final enrolment | 01/08/2015 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
KS0008
Korea, South
Sponsor information
University/education
Department of Ophthalmology
42 Jebong-ro
Dong-gu
Gwangju
501-757
Gwangju
KS0008
Korea, South
"ROR" |
https://ror.org/00f200z37 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 | 23/01/2019 | Yes | No |
| Results article | results | 15/11/2018 | 23/01/2019 | Yes | No |
Editorial Notes
23/01/2019: Publication references added
