drugset / Trial / NCT02059655
Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study)
Phase 4
Completed
31 enrolled
Cardiff University
National Institute for Social Care and Health Research · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bimatoprost | Other / unclassified | 0.03 % | Topical |