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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiff University
• Collaborator: National Institute for Social Care and Health Research
• Treatments: Benzalkonium Compounds; Bimatoprost; Dinoprost; Dinoprost tromethamine; Ophthalmic Solutions; Pharmaceutical Solutions; Tetrahydrozoline

Criteria

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.