Condition category
Eye Diseases
Date applied
04/08/2008
Date assigned
08/08/2008
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Choun-Ki Joo

ORCID ID

Contact details

Department of Ophthalmology
KangNam St. Mary's Hospital
505 Ban-Po Dong
Seocho-Ku
Seoul
137-040
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to compare the efficacy and safety of vitamin A (retinyl palmitate 0.05%) and cyclosporin A ([CsA] 0.05%) eye drops in treating patients with dry eye disease.

Ethics approval

Ethics approval received from the Institutional Review Board of KangNam St. Mary's Hospital (South Korea) on the 14th December 2006.

Study design

Prospective, randomised, controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bilateral dry eye syndrome/ophthalmology

Intervention

150 patients (300 eyes) with dry eye were divided into three groups: vitamin A (N = 50), cyclosporin A (N = 50) and control (N = 50). Patients were treated twice daily with cyclosporin A 0.05%, four times daily with retinyl palmitate (vitamin A) 0.05%, or with no eye drops. Adjunctive treatment with preservative-free artificial tears was undertaken four times a day in all groups.

Total duration of treatment for each patient was three months, and total duration of follow-up was also three months, making a total of 6 months duration.

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin A (retinyl palmitate), cyclosporin A (CsA)

Primary outcome measures

1. Symptom scoring
2. Tear film BUT
3. Schirmer test (without anaesthesia)
4. Corneal fluorescein staining
5. Conjunctival impression cytologic analysis

All performed before treatment, and at first, second and third months after initiation of treatment.

Secondary outcome measures

Goblet cell density, assessed before treatment, and at first, second and third months after initiation of treatment.

Overall trial start date

27/12/2006

Overall trial end date

14/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed informed consent
2. Male and female patients aged 21 years and over
3. Diagnosis of dry eye syndrome refractory to conventional management
4. Schirmer test (without anaesthesia) was less than 5 mm/5 minutes in at least one eye
5. Low tear film break-up time (tBUT) (less than 5 seconds)
6. Mild superficial punctate keratitis, defined as a corneal punctate fluorescein staining score of greater than or equal to 1 in either eye (scale 0 [none] to 3 [severe])
7. Symptoms of ocular irritation as assessed by an Ocular Surface Disease Index (OSDI) score of 25 or greater (on a scale of 0 - 59)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 patients (300 eyes)

Participant exclusion criteria

1. History of any ocular disorder including injury
2. Ocular infection
3. Non-dry eye ocular inflammation
4. Ocular trauma
5.Ocular surgery within the prior 6 months

Recruitment start date

27/12/2006

Recruitment end date

14/06/2007

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Ophthalmology
Seoul
137-040
Korea, South

Sponsor information

Organisation

The Catholic University of Korea (South Korea)

Sponsor details

Department of Ophthalmology and Visual Science
College of Medicine
KangNam St. Mary's Hospital
505 Ban-Po Dong
Seocho-Ku
Seoul
137-040
Korea
South

Sponsor type

University/education

Website

http://www.catholic.ac.kr/

Funders

Funder type

University/education

Funder name

The Catholic University of Korea (South Korea)

Alternative name(s)

The Catholic University of Korea, CUK

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Korea, South

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