Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study)
Condition: Graves' Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      Thyroid eye disease (TED) is a chronic disfiguring and debilitating disease of the eyes which
      can lead to sight loss in severe cases. Patients with TED frequently have characteristic
      eyeball protrusion (proptosis) due to increased fat accumulation behind the eye. The
      discomfort and changes in appearance of the eyes is a source of severe psychological distress
      and impaired quality of life in many patients. Current treatments for TED are unsatisfactory
      and established non-surgical therapies which specifically reduce proptosis are lacking.
      Reduced eyelid protrusion has recently been reported as a side-effect of the use of
      prostaglandin analogue eye drops (e.g. Bimatoprost (PGF2-alpha)) in the routine treatment of
      glaucoma and we have laboratory data showing inhibition of fat cells by Bimatoprost. Hence
      PGF2-alpha eye drops potentially represent a simple, non-invasive low toxicity topical
      alternative to surgery in TED. However no clinical trials of Bimatoprost have been conducted
      in TED to date. The objective of this study is to determine whether Bimatoprost eye drops are
      effective in reducing proptosis and thus improving quality of life in patients with TED.
      Trial participants will be recruited from the TED clinic at the University Hospital Wales.
      The clinic is a regional referral centre for the treatment and study of TED and is run by a
      multidisciplinary team of ophthalmologists, endocrinologists, and orthoptists with expertise
      in TED. Following informed consent, participants will be randomised to receive Bimatoprost or
      placebo eye drops for three months after which they will undergo a two month drug washout
      period before switching to the opposite treatment in the final three months of study. The
      primary endpoint is a change in standardised measurements of proptosis while secondary
      endpoints will include changes in quality of life scores. This study will provide evidence
      for a novel application of bimatoprost in patients with TED.
    

Intervention name(s): Bimatoprost; Eye drop solution
Intervention type(s): Drug; Drug
Intervention description(s): Artificial tear drops
Other intervention name(s): Trade Name Lumigan. MA number: EU/1/02/205/001-002. ATC Code: S01EE03; 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
Intervention MeSH terms: Benzalkonium Compounds; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Graves' disease