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

NCT02051023 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-01-08

No results posted yet for this study

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.

Conditions

  • Dry Eye

Interventions

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

Sponsors & Collaborators

  • Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

    lead OTHER

Principal Investigators

  • Margarita Calonge-Cano, MD, PhD · Ocular surface group Director - IOBA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02051023 on ClinicalTrials.gov