Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study)

NCT02059655 | Completed Phase 4

• 1 other identifier: SPON 1266-14
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Graves' Ophthalmopathy

Keywords

Graves' disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in quality of life scores on the TED quality of life questionnaire (GO-QOL)

  1 year

• Intraocular pressures

  1 year

• Side effects

  1 year

• Health economic outcomes

  1 year

Study Arms (2)

Eye drop solution

PLACEBO COMPARATOR

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

Bimatoprost

ACTIVE COMPARATOR

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.

Drug: Bimatoprost

Interventions

Bimatoprost DRUG

Also known as: Trade Name Lumigan. MA number: EU/1/02/205/001-002. ATC Code: S01EE03

Bimatoprost

Eye drop solution DRUG

Artificial tear drops

Also known as: 1 drop daily, Hypromellose Ph Eur 0.3g in 100ml, Sodium chloride, Potassium chloride, Borax, Boric acid, Benzalkonium chloride solution, Purified water, Sodium hydroxide solution (to adjust pH), Hydrochloric acid

Eye drop solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiff University: lead
• National Institute for Social Care and Health Research: collaborator

Study Sites (1)

University Hospital of Wales

Cardiff, Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Graves Disease

Interventions

Bimatoprost; Ophthalmic Solutions; Sodium Chloride; Potassium Chloride; borax; boric acid; Hydrochloric Acid

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Chlorides; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Potassium Compounds; Acids, Noncarboxylic; Acids

Study Officials

• Colin M Dayan, MA FRCP PhD

  Cardiff University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

GB (1)