Glaucoma eye drops in thyroid eye disease (BIMA Study)
- Conditions
- Graves' ophthalmopathyMedDRA version: 16.1 Level: LLT Classification code 10057889 Term: Graves' ophthalmopathy System Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-000540-15-GB
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 31
1.Stable TED with no reported change in proptosis for at least 6 months
2.Clinical activity score <3
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 (FT3 and FT4 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method