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

NCT ID: NCT01927406

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Thyroid Eye Disease; Ocular Hypertension; Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Prostaglandin Analog vs 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.

Group Type: EXPERIMENTAL

Prostaglandin Analog

Intervention Type: DRUG

The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.

Timolol

Intervention Type: DRUG

Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.

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.

Group Type: EXPERIMENTAL

Prostaglandin Analog

Intervention Type: DRUG

The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.

Interventions

Prostaglandin Analog

The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.

Intervention Type: DRUG

Timolol

Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.

Intervention Type: DRUG

Other Intervention Names

Bimatoprost; Travoprost Z; Tafluprost; Latanoprost; Timolol maleate 0.5%

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Andrea L Kossler

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea L. Kossler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Hospital and Clinics

Stanford, California, United States

Countries

United States

Other Identifiers

26654

Identifier Type: -

Identifier Source: org_study_id