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Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study)

NCT02059655 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-05-06

No results posted yet for this study

Summary

The purpose of the study is to establish whether Bimatoprost eye drops are effective in reducing proptosis in inactive thyroid eye disease (TED) patients and improving quality of life in patients with TED. Current standard NHS treatment/care for inactive TED is artificial tears (used as the placebo in this study) or surgery if appropriate.

The IMP is Bimatoprost eye drops PGF2α (0.03%). This is already licensed eye drops usually used for glaucoma. Therefore the current trial's indication is outside its licenced indication. The Investigational Medicinal Product (IMP) will be used according to its licenced dosage and form. This is the first time that Bimatoprost will be used in the treatment of TED

Conditions

  • Graves' Ophthalmopathy

Interventions

DRUG

Bimatoprost

DRUG

Eye drop solution

Artificial tear drops

Sponsors & Collaborators

  • National Institute for Social Care and Health Research

    collaborator UNKNOWN

  • Cardiff University

    lead OTHER

Principal Investigators

  • Colin M Dayan, MA FRCP PhD · Cardiff University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United Kingdom

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 NCT02059655 on ClinicalTrials.gov