Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study) (BIMA)
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
|Graves' Ophthalmopathy||Drug: Bimatoprost Drug: Eye drop solution||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prostaglandin F2-alpha Eye Drops (Bimatoprost) in Thyroid Eye Disease: a Randomised Controlled Double Blind Crossover Trial|
- The primary endpoint of this study will be comparison of the change in ophthalmometry readings over the two 3 month treatment periods. [ Time Frame: 1 year ]Reduction of 2 mm or more is regarded as clinically relevant
- Change in quality of life scores on the TED quality of life questionnaire (GO-QOL) [ Time Frame: 1 year ]Whether there has been an improvement in patients' quality of life
- Intraocular pressures [ Time Frame: 1 year ]Whether there has been a change in intraocular pressures
- Side effects [ Time Frame: 1 year ]
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
- Health economic outcomes [ Time Frame: 1 year ]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
|Study Start Date:||November 2014|
|Study Completion Date:||March 2016|
|Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Eye drop solution
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.
Drug: Eye drop solution
Artificial tear drops
Active Comparator: Bimatoprost
1 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.
Other Name: Trade Name Lumigan. MA number: EU/1/02/205/001-002. ATC Code: S01EE03
Please refer to this study by its ClinicalTrials.gov identifier: NCT02059655
|University Hospital of Wales|
|Cardiff, United Kingdom, CF14 4XW|
|Principal Investigator:||Colin M Dayan, MA FRCP PhD||Cardiff University|