- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02059655
Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study) (BIMA)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Cardiff, United Kingdom, CF14 4XW
- University Hospital of Wales
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stable TED with no reported change in proptosis for at least 6 months. See section 4.1.1 for TED definition;
- Clinical activity score <3 (Appendix 1);
- Proptosis (subjective unilateral proptosis confirmed by asymmetry in exophthalmometry of >2mm OR greater than 20 mm on exophthalmometry measurement in one eye);
- Euthyroid (thyroid function tests in the reference range);
- 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:
- Age <18 yrs;
- Dysthyroid optic neuropathy unless previously treated;
- Pregnancy or lactation;
- Previous Corneal Herpes Simplex infection;
- On therapy for glaucoma or intraocular hypertension;
- Less than 6 months from prior systemic steroid use;
- Aphakia, pseudophakia with torn posterior lens capsule or anterior chamber lenses;
- Patient with risk factors for cystoid macular oedema, iritis or uveitis;
- Severe Asthma (risk of severe allergic reaction to medication);
- Previous allergy to Bimatoprost or preservative.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Artificial tear drops
Other Names:
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Reduction of 2 mm or more is regarded as clinically relevant
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Intraocular pressures
Time Frame: 1 year
|
Whether there has been a change in intraocular pressures
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1 year
|
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:
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1 year
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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
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1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Colin M Dayan, MA FRCP PhD, Cardiff University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Genetic Diseases, Inborn
- Thyroid Diseases
- Eye Diseases, Hereditary
- Graves Disease
- Exophthalmos
- Orbital Diseases
- Goiter
- Hyperthyroidism
- Eye Diseases
- Graves Ophthalmopathy
- Antihypertensive Agents
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Ophthalmic Solutions
- Pharmaceutical Solutions
- Bimatoprost
- Benzalkonium Compounds
Other Study ID Numbers
- SPON 1266-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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