Clinical effect of anti-oxidant glasses in dry eye
| ISRCTN | ISRCTN71217488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71217488 |
| Secondary identifying numbers | OP00082 |
- Submission date
- 13/06/2015
- Registration date
- 23/06/2015
- Last edited
- 10/07/2023
- 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 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
Contact information
Scientific
Department of Ophthalmology
Chonnam National University Medical School and Hospital
42 Jebong-ro
Dong-gu
Gwangju
KS0008
Korea, South
 ORCID ID |
0000-0002-2788-1851 |
|---|---|
| Phone | +82 (0)62 220 6741 |
| kcyoon@jnu.ac.kr |
Study information
| Study design | Prospective multicenter double-blind randomized placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | Local delivery of anti-oxidant agents using glasses might be effective in controlling oxidative damages in dry eye disease. |
| Ethics approval(s) | Institutional Review Board of the Chonnam National University Hospital, Chung-Ang University Hospital and the Korean Food and Drug Administration (No. MDCTC_2011_BM) |
| 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 | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| 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 study start date | 17/08/2012 |
| Completion date | 31/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 28/09/2012 |
| Date of final enrolment | 28/03/2013 |
Locations
Countries of recruitment
- Korea, South
Study participating centres
Chonnam National University Medical School and Hospital
42 Jebong-ro Dong-gu
Gwangju
KS0008
Korea, South
Heukseok-dong
Dongjak-Gu
Seoul
KS013
Korea, South
Sponsor information
University/education
Department of Ophthalmology
42 Jebong-ro
Dong-gu
Gwangju
Gwangju
KS0008
Korea, South
| Website | http://www.cnuh.com |
|---|---|
"ROR" |
https://ror.org/00f200z37 |
University/education
Chung-Ang University Hospital 224-1
Heukseok-dong
Dongjak-Gu
Seoul
KS0013
Korea, South
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 | 12/10/2015 | Yes | No | |
| Dataset | 12/10/2015 | 10/07/2023 | No | No | |
| Protocol (other) | 12/10/2015 | 10/07/2023 | No | No |
Editorial Notes
10/07/2023: Protocol and dataset added.
27/11/2015: Publication reference added.
18/08/2015: Chonnam National University Hospital Biomedical Research Institute has been added as a funder of the trial.
