BIMAtoprost eye drops in thyroid eye disease

Not Applicable

Completed

• Conditions: Graves' eye disease; Nutritional, Metabolic, Endocrine; Graves disease

• Registration Number: ISRCTN46696624
• Lead Sponsor: Cardiff University (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30880626 (added 13/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-14
• Study Completion: 2016-04-15
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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 >2 mm 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, intrauterine device (IUD) and condom, diaphragm with spermicide and condom

Exclusion Criteria

1. Age <18 years
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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in proptosis measurement; reduction of 2 mm or more would be regarded as clinically relevant. Measured at all visits (baseline, 2, 3, 4, 5). Measured by exophthalmometry readings by Hertel exophthalmometer.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change in quality of life scores: measured at visits 1, 2, 3, 4, 5. Measured by EUGOGO GO-Quality of Life and EQ-5D-5L Health Questionnaire<br> 2. Side effects: measured at visits 2, 3, 4, 5. Standardised questionnaire in the form of a patient diary log. Patients will be requested to record any side effects in their diary<br> 3. Change in intraocular pressure: measured at visits baseline, 2, 3, 4, 5. Measured by Goldmann Applanation Tonometer<br> 4. Health economic cost: measured at visits 1, 2, 3, 4, 5. Measured by Client Service Receipt Inventory (CSRI)<br>