Comparison of vitamin A and cyclosporin 0.05% eye drops for treatment of dry eye syndrome

ISRCTN ISRCTN47762748
DOI https://doi.org/10.1186/ISRCTN47762748
Secondary identifying numbers N/A
Submission date
04/08/2008
Registration date
08/08/2008
Last edited
08/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Choun-Ki Joo
Scientific

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

Study information

Study designProspective, randomised, controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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(s)Ethics approval received from the Institutional Review Board of KangNam St. Mary's Hospital (South Korea) on the 14th December 2006.
Health condition(s) or problem(s) studiedBilateral dry eye syndrome/ophthalmology
Intervention150 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 typeSupplement
Primary outcome measure1. 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 measuresGoblet cell density, assessed before treatment, and at first, second and third months after initiation of treatment.
Overall study start date27/12/2006
Completion date14/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants150 patients (300 eyes)
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment27/12/2006
Date of final enrolment14/06/2007

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Department of Ophthalmology
Seoul
137-040
Korea, South

Sponsor information

The Catholic University of Korea (South Korea)
University/education

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

Website http://www.catholic.ac.kr/
ROR logo "ROR" https://ror.org/01fpnj063

Funders

Funder type

University/education

The Catholic University of Korea (South Korea)
Private sector organisation / Universities (academic only)
Alternative name(s)
The Catholic University of Korea, 가톨릭 대학교, CUK
Location
Korea, South

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan