Condition category
Eye Diseases
Date applied
13/06/2015
Date assigned
23/06/2015
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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

17/08/2012

Overall trial end date

31/05/2013

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

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

http://www.cnuh.com

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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26457673

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.