Condition category
Eye Diseases
Date applied
20/01/2014
Date assigned
05/02/2014
Last edited
17/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Studies show that preservatives in eye drop can trigger an inflammatory response. To the best of our knowledge, there is no report comparing the effects of preservative-free and preserved eye drops in dry eye syndrome. This study compares the antioxidants and inflammatory responses in tears of patients with dry eye syndrome treated with preservative-free eye drops versus eye drops with preservatives.

Who can participate?
21 years of age and over and diagnosed with dry eye syndrome.

What does the study involve
Participants were randomly allocated to receive either preservative-free eye drops or eye drops with preservatives. Various assessments will be carried out at the start of the study and at 1, 2 and 3 months after treatment.

What are the possible benefits and risks of participating?
Both preservative-free and preserved eye drops treatments may lead to significant improvement in symptoms of dry eye. There is no risk to participants.

Where is the study run from?
Bucheon St Mary's Hospital, South Korea.

When is the study starting and how long is it expected to run for?
The study started in September 2012 and ran until December 2013.

Who is funding the study?
National Research Foundation of Korea (NRF).

Who is the main contact?.
Professor Eun Chul Kim

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eun Chul Kim

ORCID ID

Contact details

Bucheon St. Mary's Hospital
#2
Sosa-Dong
Wonmi-Gu
Bucheon
Kyungki-Do
Bucheon
420-717
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of antioxidant and inflammatory cytokine activities in tears of patients with dry eye syndrome treated with preservative-free vs preserved eye drops

Acronym

Study hypothesis

Dry eye syndrome is recognized as a highly prevalent inflammatory disease of the lacrimal functional unit caused by multifactorial reasons. Increase of the oxidative stress status in the conjunctiva of Sjogren syndrome patients appears to have a role in the pathogenesis of dry eye disease. Preservatives in eye drops can induce oxidative stress and inflammatory response in conjunctival epithelial cells and the rabbit dry eye model.

Ethics approval

Institutional Review Board at the Bucheon St. Mary's Hospital, 21/08/2013

Study design

Randomized comparative 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 the contact details below to request a patient information sheet

Condition

Dry eye syndrome

Intervention

Permuted blocks were obtained using a computer-based random code generator (Research Randomizer; http://randomizer.org/).

50 patients (Group 1) were treated four times with preservative-free 0.1% sodium hyaluronate and 0.1% fluorometholone for the first month and preservative-free 0.1% sodium hyaluronate and 0.05% cyclosporine for the second and third month.

50 patients (Group 2) were treated four times with preserved 0.1% sodium hyaluronate and preserved 0.1% fluorometholone for the first month and preserved 0.1% sodium hyaluronate and 0.05% cyclosporine for the second and third month.

Following instillation of the eye drops, symptoms and signs of dry eye are measured.

Total duration of treatment and follow-up for each study arm: 3 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Ocular surface disease index (OSDI)
2. Corneal fluorescein staining
3. Schirmer tear test (without anesthesia)
4. Tear film break-up time (tBUT)
5. Symptom score of dry eye
6. Impression cytology

Measured at baseline, 1, 2 and 3 months.

Secondary outcome measures

Antioxidant and Inflammatory cytokine activities in tears measured by ELISA at baseline, 1, 2 and 3 months.

Overall trial start date

01/09/2012

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible patients were at least 21 years of age and had a diagnosis of dry eye syndrome refractory to conventional management. Inclusion criteria were:
1. Schirmer test (without anesthesia) of 5 mm/5 minutes in at least one eye
2. Low tear film break-up time (tBUT) (<5 seconds)
3. Mild superficial punctate keratitis, defined as a corneal punctate fluorescein staining score of ≥1 in either eye (scale 0 [none] to 3 [severe]); and one or more moderate (≥2) dry eye related symptoms, including itching, burning, blurred vision, foreign body sensation, dryness, photophobia, soreness, or pain.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Group 1 (50 patients) was treated with preservative-free eye drops and group 2 (50 patients) was treated with preserved eye drops.

Participant exclusion criteria

Patients were excluded if they had:
1. A history of any ocular disorder including injury, infection, non-dry-eye ocular inflammation, trauma, or surgery within the prior 6 months
2. Were receiving concurrent treatment that could interfere with interpretation of the study results
3. Had any uncontrolled systemic disease or significant illness; or were pregnant, lactating, or considering becoming pregnant.
4. Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative or personal reasons.

Recruitment start date

01/09/2012

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Korea, South

Trial participating centre

Bucheon St. Mary's Hospital
Bucheon
420-717
Korea, South

Sponsor information

Organisation

Bucheon St. Mary's Hospital (Korea, South)

Sponsor details

c/o Eun Chul Kim
#2
Sosa-Dong
Wonmi-Gu
Bucheon
Kyungki-Do
Bucheon
420-717
Korea
South

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

The National Research Foundation of Korea (NRF) (Korea, South)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes