Graves' Ophthalmopathy | Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study)
Graves' Ophthalmopathy research study
What is the primary objective of this study?
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
Who is eligible to participate?
Inclusion Criteria: 1. Stable TED with no reported change in proptosis for at least 6 months. See section 4.1.1 for TED definition; 2. Clinical activity score <3 (Appendix 1); 3. Proptosis (subjective unilateral proptosis confirmed by asymmetry in exophthalmometry of >2mm OR greater than 20 mm on exophthalmometry measurement in one eye); 4. Euthyroid (thyroid function tests in the reference range); 5. If female, must be using a reliable form of contraception during the trial, e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicide and condom. Exclusion Criteria: 1. Age <18 yrs; 2. Dysthyroid optic neuropathy unless previously treated; 3. Pregnancy or lactation; 4. Previous Corneal Herpes Simplex infection; 5. On therapy for glaucoma or intraocular hypertension; 6. Less than 6 months from prior systemic steroid use; 7. Aphakia, pseudophakia with torn posterior lens capsule or anterior chamber lenses; 8. Patient with risk factors for cystoid macular oedema, iritis or uveitis; 9. Severe Asthma (risk of severe allergic reaction to medication); 10. Previous allergy to Bimatoprost or preservative.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Eye drop solutionArtificial tear drops
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Eye drop solutionPatients will receive 1 dose daily over 3 month period followed by 2 months washout period. Subsequently patient will cross over to the opposite treatment and continue further treatment for 3 month period.
Bimatoprost1 drop daily of Bimatoprost 0.03%. Patients will receive 1 dose daily over 3 month period followed by 2 months washout period. Subsequently patient will cross over to the opposite treatment and continue further treatment for 3 month period.
Start Date: November 2014
Completed Date: March 2016
Phase: Phase 4
Primary Outcome: The primary endpoint of this study will be comparison of the change in ophthalmometry readings over the two 3 month treatment periods.
Secondary Outcome: Change in quality of life scores on the TED quality of life questionnaire (GO-QOL)
Study sponsors, principal investigator, and references
Principal Investigator: Colin M Dayan, MA FRCP PhD
Lead Sponsor: Cardiff University
Collaborator: National Institute for Social Care and Health Research