drugset / Trial / NCT02059655

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

NCT02059655

RandomizedCrossoverQuadruple-blindTreatment

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

Timeline

Start
2014-11
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bimatoprost Other / unclassified 0.03 % Topical