Skip to content

To compare safety and efficacy of cyclosporine 0.05% and cyclosporine 0.09% eyedrops for dry eye (keratoconjunctivitis).

To compare safety and efficacy of cyclosporine 0.05% and cyclosporine 0.09% eyedrops for dry eye (keratoconjunctivitis). - Cyclosporine 0.05% versus 0.09% for dry eye.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035991
Enrollment
40
Registered
2019-02-24
Start date
2019-02-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Dry Eye Syndrome

Interventions

Group 1 received cyclosporine 0.05% eye drops twice daily for 12 weeks Group 2 received cyclosporine 0.09% eye drops twice daily for 12 weeks.

Sponsors

Laser Eye Clinic Noida
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects experiencing dry eye symptoms.

Exclusion criteria

Exclusion criteria: Patients with current ocular infection, history of laser in situ keratomileusis, allergic conjunctivitis, herpetic eye disease, diabetes, and liver diseases were excluded. Other exclusion criteria were pregnant or lactating mothers, HIV, and hepatitis B and C. Patients who were allergic to fluorescein were excluded. Systemic (tetracyclines and corticosteroids) or topical medications (other than artificial tear supplements) that could affect tear production or meibomian gland functions were discontinued before intervention. However, patients were instructed not to use artificial tear preparations, 2 hours before testing. Computer work was not allowed during the course of the study as concurrent use of visual display terminals may independently influence ocular surface changes.

Design outcomes

Primary

MeasureTime frame
Change from baseline in subjective dry eye symptoms score.

Secondary

MeasureTime frame
Change from baseline in the Schirmer-1 test values as a measure of tear production, TBUT as a measure of tear film stability, and CIC scores (Nelson grade) for cellular morphology and Goblet cell density.

Countries

Asia(except Japan)

Contacts

Public ContactDeshbandhu Sood

Citizen Right Protection Forum NGO

anujsafety@gmail.com919817062276

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026