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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Kyung Chul Yoon
Scientific

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

ORCiD logoORCID ID 0000-0002-2788-1851
Phone +82 (0)62 220 6741
Email kcyoon@jnu.ac.kr

Study information

Study designProspective multicenter double-blind randomized placebo-controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleClinical 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 objectivesLocal 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) studiedDry 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
InterventionPatients 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)-
Primary outcome measureChange 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 measures1. 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 date17/08/2012
Completion date31/05/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteria1. 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 criteria1. 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 enrolment28/09/2012
Date of final enrolment28/03/2013

Locations

Countries of recruitment

  • Korea, South

Study participating centres

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
Chung-Ang University Hospital
Chung-Ang University Hospital 224-1
Heukseok-dong
Dongjak-Gu
Seoul
KS013
Korea, South

Sponsor information

Chonnam National University Hospital
University/education

Department of Ophthalmology
42 Jebong-ro
Dong-gu
Gwangju
Gwangju
KS0008
Korea, South

Website http://www.cnuh.com
ROR logo "ROR" https://ror.org/00f200z37
Chung-Ang University Hospital
University/education

Chung-Ang University Hospital 224-1
Heukseok-dong
Dongjak-Gu
Seoul
KS0013
Korea, South

Funders

Funder type

Industry

BM Biotechnology Co., Ltd.

No information available

Chonnam National University Hospital Biomedical Research Institute

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planTo 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.