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
Scientific
Department of Ophthalmology
KangNam St. Mary's Hospital
505 Ban-Po Dong, Seocho-Ku
Seoul
137-040
Korea, South
Study information
| Study design | Prospective, randomised, controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 27/12/2006 |
| Completion date | 14/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 patients (300 eyes) |
| Key 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) |
| Key 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 |
| Date of first enrolment | 27/12/2006 |
| Date of final enrolment | 14/06/2007 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Department of Ophthalmology
Seoul
137-040
Korea, South
137-040
Korea, South
Sponsor information
The Catholic University of Korea (South Korea)
University/education
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" |
https://ror.org/01fpnj063 |
Funders
Funder type
University/education
The Catholic University of Korea (South Korea)
Private sector organisation / Universities (academic only)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
