Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Kyung Chul Yoon
ORCID ID
http://orcid.org/0000-0002-2788-1851
Contact details
Department of Ophthalmology
Chonnam National University Medical School and Hospital
42 Jebong-ro
Dong-gu
Gwangju
501-757
Gwangju
KS0008
Korea
South
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Institutional Review Board of Chonnam National University Hospital, 10/07/2014, IRB No. CNUH 2014-171
Study design
Single-center randomized double-masked vehicle-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
1-(Diisopropyl-phosphinoyl)-nonane
Primary outcome measures
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 trial start date
01/01/2015
Overall trial end date
31/08/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
At least 40 patients (20 patients in each group)
Participant 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
Recruitment start date
01/07/2015
Recruitment end date
01/08/2015
Locations
Countries of recruitment
Korea, South
Trial participating centre
Department of Ophthalmology
Chonnam National University Medical School and Hospital
KS0008
Korea, South
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary