The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Bimatoprost; Latanoprost; Timolol; Travoprost

Criteria

Inclusion Criteria:

• mild or moderate to severe thyroid eye disease in one or both eyes

• age > 18 years

• informed consent

• intraocular pressure > 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes

• not on current prostaglandin analog intraocular pressure lowering therapy

Exclusion Criteria:

• sight threatening thyroid eye disease

• children < 18 years old

• patients that are not compliant with treatment or follow-up

• patients already on prostaglandin analog treatment

• patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up

• patients that cannot tolerate prostaglandin analog treatment.

• patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.