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
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