NCT02051023

Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)

Randomized, Double-Masked, Vehicle-controlled Phase III Trial on the Safety/Efficacy of FML® 0.1% in the Treatment of the Inflammatory Exacerbation Provoked by Exposure to an Adverse Controlled Environment in Patients With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypothesis: Fluorometholone (FML) 0.1% eyedrops topically applied 4 times a day for 22 days is more efficient than artificial tears (Liquifilm) in dry eye disease (DED) and ameliorates the worsening of the disease after exposure to an adverse controlled environment.

Detailed description

There will be 4 visits in 3 different days: Visit 1 (V1). Inclusion in normalized controlled environment (NCE) Visit 2 (V2). 21 days post-treatment. Data collected in NCE Visit 3 (V3). 21 days post-treatment. Data collected in adverse controlled environment (ACE) Visit 4 (V4). 22 days post-treatment. Recovery visit in ACE. Data collected in NCE

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	FML 0.1% eyedrops	Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days
DRUG	Liquifilm artificial tears eyedrops	Liquifilm instillation 4 times a day for 22 days

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-01-31
• Last updated: 2015-01-08

Locations

2 sites across 1 country: Spain