Condition category
Eye Diseases
Date applied
10/12/2015
Date assigned
14/12/2015
Last edited
14/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

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

OP00169

Study information

Scientific title

Clinical effect of anti-oxidant pads containing extracts of Chamaecyparis obtusa and Camellia japonica in patients with dry eye disease.

Acronym

Study hypothesis

Local delivery of anti-oxidant agents using pads might be effective in controlling oxidative damages in dry eye disease.

Ethics approval

Institutional Review Board of the Chonnam National University Hospital, 26/11/2015, ref: CNUH-2015-232

Study design

Prospective 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

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

Primary outcome measures

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

14/11/2015

Overall trial end date

14/12/2016

Reason abandoned

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

14/12/2015

Recruitment end date

14/01/2016

Locations

Countries of recruitment

Korea, South

Trial participating centre

Chonnam National University Medical School and Hospital
Department of Ophthalmology 42 Jebong-ro Dong-gu
Gwangju
KS0008
Korea, South

Sponsor information

Organisation

Korea Forest Service

Sponsor details

189 Cheongsa-ro
Seo-gu
대전광역시 서구 청사로 189 1동
Daejeon
35208
Korea
South
+82-1588-3249
m-foa@forest.go.kr

Sponsor type

Government

Website

http://www.forest.go.kr/newkfsweb/kfs/idx/Index.do?mn=KFS_01

Funders

Funder type

Government

Funder name

Korea Forest Service

Alternative name(s)

KFS

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Korea, South

Results and Publications

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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes