Clinical effect of anti-oxidant pads in patients with dry eye
| ISRCTN | ISRCTN10704205 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10704205 |
| Secondary identifying numbers | OP00169 |
- Submission date
- 10/12/2015
- Registration date
- 14/12/2015
- Last edited
- 17/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Dry eye disease (or dry eye syndrome) is a common eye condition in which the eyes do not make enough tears or the tears evaporate too quickly. This causes the eyes to dry out, resulting in them becoming irritated, red and swollen. Sufferers may find that their eyelids have become stuck together overnight when they wake up. They may also experience blurred vision that improves after blinking. The aim of this study is to test anti-oxidant pads containing the plant extracts of Chamaecyparis obtusa and Camellia japonica to see whether they can help control the condition and alleviate symptoms.
Who can participate?
Adult patients with dry eye.
What does the study involve?
Patients are randomly allocated to either the treatment or the placebo (control) group. All participants are given glasses that are designed to wrap around the eye and hold eye pads in place. Participants in the treatment group are given eye pads that contain extracts of Chamaecyparis obtusa and Camellia japonica. Participants in the placebo group are also given eye pads but these do not contain the plant extracts. All participants wear the glasses while asleep for 4 weeks.
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 pads.
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?
November 2015 to December 2016.
Who is funding the study?
Forest Science and Technology Projects provided by the Korea Forest Service
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 double-blind randomized placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clinical effect of anti-oxidant pads containing extracts of Chamaecyparis obtusa and Camellia japonica in patients with dry eye disease. |
| Study hypothesis | Local delivery of anti-oxidant agents using pads might be effective in controlling oxidative damages in dry eye disease. |
| Ethics approval(s) | Institutional Review Board of the Chonnam National University Hospital, 26/11/2015, ref: CNUH-2015-232 |
| Condition | Dry eye |
| Intervention | Patients were randomly assigned to either the treatment or the placebo group. All participants are given glasses composed of an external supporting cover that can be easily attached and detached from the face. The external supporting part of the glasses has been designed to wrap around the eye. Participants in the treatment group are given eye pads to be inserted into the glasses that contain extracts of Chamaecyparis obtusa and Camellia japonica. Participants in the placebo group are also given eye pads but these do not contain the plant extracts. All participants wear the glasses while asleep for 4 weeks. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| 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 | 14/11/2015 |
| Overall study end date | 14/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| 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 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 | 14/12/2015 |
| Recruitment end date | 14/01/2016 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
42 Jebong-ro Dong-gu
Gwangju
KS0008
Korea, South
Sponsor information
Government
189 Cheongsa-ro
Seo-gu
대전광역시 서구 청사로 189 1동
Daejeon
35208
Korea, South
| Phone | +82-1588-3249 |
|---|---|
| m-foa@forest.go.kr | |
| Website | http://www.forest.go.kr/newkfsweb/kfs/idx/Index.do?mn=KFS_01 |
"ROR" |
https://ror.org/05bjbww34 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- KFS
- Location
- Korea, South
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 | After completing this study, we would like to publish on SCI journal as soon as possible. Our study will demonstrate clinical effect of Chamaecyparis obtusa and Camellia japonicaor on dry eye disease. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2017 | 17/08/2020 | Yes | No |
Editorial Notes
17/08/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
