deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02051023

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

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

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

Conditions Dry Eye
Updated 6 times since 2017 Last updated: Jan 7, 2015 Started: Feb 28, 2014 Primary completion: Dec 31, 2014 Completion: Dec 31, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Dry Eye, this trial is completed. The trial is conducted by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA and has accumulated 6 data snapshots since 2014. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotCompleted~Mar 2019 – ~Jan 2021 · 22 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  4. Mar 2019 — Jan 2021 [monthly]

    Completed PHASE3

  5. Jun 2018 — Mar 2019 [monthly]

    Completed PHASE3

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Feb 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Data source: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations