Once-daily Fluorometholone Vs Twice-daily Cyclosporine in Dry Eye Disease

Korea University

Status and phase: Completed; Phase 4

Conditions: Dry Eye Disease (DED)

Treatments: Drug: Fluorometholone 0.1% ophthalmic solution; Drug: Cyclosporine 0.05% eye drops

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06876116

2022AN0569

Details and patient eligibility

About

This study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment in dry eye disease.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. participants aged 18 years or older
2. complaint of dry eye symptoms for 6 months or longer at screening
3. ocular surface disease index (OSDI) score of 33 or higher
4. tear film breakup time of 7 seconds or less

Exclusion criteria

1. abnormal lid anatomy or active blepharitis
2. severe systemic autoimmune diseases
3. received permanent lacrimal plug within 3 months
4. DED secondary to alkali burns, cicatricial pemphigoid, or Stevens-Johnson syndrome
5. ocular/periocular malignancy
6. active ocular allergies or allergy to the study drug or its components
7. active infection
8. intraocular surgery or ocular laser surgery within 6 months
9. uncontrolled systemic disease or history of herpetic keratitis
10. contact lens user
11. intraocular pressure >25mmHg
12. pregnancy or current breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

once-daily fluorometholone 0.1% group

Active Comparator group

Description:

After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with fluorometholone 0.1% once a day for 8 weeks.

Treatment:

Drug: Fluorometholone 0.1% ophthalmic solution

twice-daily cyclosporine 0.05% group

Active Comparator group

Description:

After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with cyclosporine 0.05% twice a day for 8 weeks.

Treatment:

Drug: Cyclosporine 0.05% eye drops