Graves' Ophthalmopathy Clinical Trial
— BIMAOfficial title:
Prostaglandin F2-alpha Eye Drops (Bimatoprost) in Thyroid Eye Disease: a Randomised Controlled Double Blind Crossover Trial
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
Status | Completed |
Enrollment | 31 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital of Wales | Cardiff |
Lead Sponsor | Collaborator |
---|---|
Cardiff University | National Institute for Social Care and Health Research |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint of this study will be comparison of the change in ophthalmometry readings over the two 3 month treatment periods. | Reduction of 2 mm or more is regarded as clinically relevant | 1 year | Yes |
Secondary | Change in quality of life scores on the TED quality of life questionnaire (GO-QOL) | Whether there has been an improvement in patients' quality of life | 1 year | No |
Secondary | Intraocular pressures | Whether there has been a change in intraocular pressures | 1 year | No |
Secondary | Side effects | To consider the side effect profiles of Bimatoprost in TED patients during the study. Expected Adverse Reactions to the trial treatment(s) are detailed below: Commonly occurring cosmetic effects (approximate incidence) Conjunctival redness (0.5%); Lengthening of eyelashes - (average elongation 0.7mm); Darkening of eye lashes (45-57%); Peri-ocular skin pigmentation (3%); Darkening of the iris (10.1%). Rare but potentially serious side effects (limited information available) Iris cysts; Cystoid macular oedema; Anterior uveitis; Reactivation of herpes simplex virus infection |
1 year | Yes |
Secondary | Health economic outcomes | The primary intention of the economic evaluation is to explore the cost associated with TED treatment. In theory, Bimatoprost intervention would lead to the net cost savings to NHS in comparison to surgical rehabilitation that the patient otherwise will go through. We are aware of limitation in the trial design as this trial primary intention is to evaluate efficacy of Bimatoprost in TED, not to follow up patients until they might need surgery. However it would be useful to collect the resource use and quality of life data during this trial period on a pilot basis which may lead to a larger health economic focus study in the future. It is not envisaged that the crossover design will yield data that could allow a meaningful incremental cost-effectiveness ratio (ICER) to be calculated for Bimatoprost against placebo, as the duration of effects on perceived quality of life cannot be predicted in advance | 1 year | No |
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