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 clinical effectiveness and safety of wearable anti-oxidant glasses containing extracts of medicinal plants in patients with mild dry eye disease.
Who can participate?
Patients with mild dry eye.
What does the study involve?
Participants were randomly allocated to wear either glasses containing extracts of anti-oxidant medicinal plants or normal glasses. The glasses were applied for 15 minutes, three times a day. The participants' symptoms were evaluated at the start of the study and 4 and 8 weeks after treatment.
What are the possible benefits and risks of participating?
The participants' symptoms could improve. There is a risk of unknown side effects wearing anti-oxidant containing glasses.
Where is the study run from?
1. Department of Ophthalmology, Chonnam National University Medical School and Hospital (South Korea)
2. Department of Ophthalmology, Chung-Ang University Hospital, Chung-Ang University College of Medicine (South Korea).
When is the study starting and how long is it expected to run for?
From September 2012 to March 2013.
Who is funding the study?
1. BM Biotechnology Co., Ltd. (South Korea)
2. Chonnam National University Hospital Biomedical Research Institute (Korea)
Who is the main contact?
Prof. 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
KS0008
Korea
South
+82 (0)62 220 6741
kcyoon@jnu.ac.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OP00082
Study information
Scientific title
Clinical effect of anti-oxidant glasses containing extracts of medicinal plants in patients with dry eye disease: a multi-center, prospective, randomized, double-blind, placebo-controlled trial
Acronym
Study hypothesis
Local delivery of anti-oxidant agents using glasses might be effective in controlling oxidative damages in dry eye disease.
18/08/2015: 'Chonnam National University Hospital Biomedical Research Institute' has been added as a funder of the trial.
Ethics approval
Institutional Review Board of the Chonnam National University Hospital, Chung-Ang University Hospital and the Korean Food and Drug Administration (No. MDCTC_2011_BM)
Study design
Prospective multicenter double-blind randomized placebo-controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Patients were randomly assigned to either the treatment or the placebo group. Participants inthe treatment group received commercially available glasses (EPA II-alpha, BM Biotechnology, Sunchon, South Korea) with a pad containing four anti-oxidant medicinal plant extracts including Schizonepeta tenuifolia var. japonica Kitagawa, Angelica dahurica Bentham ET hooker, Rehmannia glutinosa Liboschitz var. purpurea Makino, and Cassia tora L. Each treatment session was 15 minutes long and both groups underwent a treatment session three times a day for 8 weeks.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Change in subjective symptoms of dry eye disease. The subjective symptoms were graded using ocular surface disease index (OSDI) score (0 to 100), with higher scores representing greater disability. The patients answered the 12 items on the OSDI questionnaire that were graded on a scale of 0 to 4 (0: none of the time, 1: some of the time, 2: half of the time, 3: most of the time, 4: all of the time). The OSDI was calculated by ([sum of scores for all questions answered]×100)/([total number of questions answered]×5). The OSDI score was evaluated at baseline, 4 weeks, and 8 weeks after treatment.
Secondary outcome measures
1. Tear film break up time - 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. Schirmer’s test (with anesthesia)
Both evaluated at baseline, 4 weeks, and 8 weeks after treatment.
Overall trial start date
17/08/2012
Overall trial end date
31/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. One or more dry eye-related ocular symptoms (> 3 months) such as dryness, irritation and burning sensations
2. Ocular Surface Disease Index score from 13 to 32 (mild to moderate)
3. Tear film break-up time (BUT) of <10 s or a Schirmer’s test (with application of a local anaesthetic) value <10 mm for 5 minutes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Pregnant women
2. Active eye and periocular skin inflammation
3. Vitamin A deficiency
4. Previous ocular surgery within 3 months
5. History of diabetic retinopathy, age-related macular degeneration, glaucoma
6. History of wearing contact lenses
7. History of active treatment for dry eyes such as punctal occlusion or the usage of anti-inflammatory eye drops (topical steroid or topical cyclosporin) within 1 month
8. Systemic condition or medication that could cause dry eye
Recruitment start date
28/09/2012
Recruitment end date
28/03/2013
Locations
Countries of recruitment
Korea, South
Trial participating centre
Chonnam National University Medical School and Hospital
Department of Ophthalmology
Chonnam National University Medical School and Hospital
42 Jebong-ro Dong-gu
Gwangju
KS0008
Korea, South
Trial participating centre
Chung-Ang University Hospital
Chung-Ang University Hospital 224-1
Heukseok-dong
Dongjak-Gu
Seoul
KS013
Korea, South
Sponsor information
Organisation
Chonnam National University Medical School and Hospital
Sponsor details
Department of Ophthalmology
42 Jebong-ro
Dong-gu
Gwangju
Gwangju
KS0008
Korea
South
Sponsor type
University/education
Website
Organisation
Chung-Ang University Hospital
Sponsor details
Chung-Ang University Hospital 224-1
Heukseok-dong
Dongjak-Gu
Seoul
KS0013
Korea
South
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
BM Biotechnology Co., Ltd.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Chonnam National University Hospital Biomedical Research Institute
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
Other
Basic results (scientific)
Publication list
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26457673