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

Phase 4

Withdrawn

• Conditions: Glaucoma; Ocular Hypertension; Thyroid Eye Disease
• Interventions: Drug: Prostaglandin Analog; Drug: Timolol

• Registration Number: NCT01927406
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-22
• Study Start: 2014-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prostaglandin Analog vs Timolol	Prostaglandin Analog	In this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day.
Prostaglandin Analog	Prostaglandin Analog	In this group, with thyroid eye disease and increased intraocular pressure in only one eye Prostaglandin Analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one, affected eye.
Prostaglandin Analog vs Timolol	Timolol	In this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day.

Primary Outcome Measures

Name	Time	Method
Change from baseline in appearance of facial periorbital region at 6 months.	Baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.	Baseline and 3, 6, 9 and 12 months
Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.	Baseline and 3, 6, 9 and 12 months
Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months.	Baseline and 3, 6, 9 and 12 months

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States