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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47762748
Enrollment
150
Registered
2008-08-08
Start date
2006-12-27
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral dry eye syndrome/ophthalmology Eye Diseases Disorders of lacrimal system

Interventions

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

Sponsors

The Catholic University of Korea (South Korea)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026