NCT03708627

Brief Summary

Testing whether Bimatoprost, a topical eye drop used for glaucoma, can be used to induce periorbital fat atrophy in patients with Graves' disease

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
62mo left

Started Nov 2017

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Nov 2017Jul 2031

Study Start

First participant enrolled

November 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

11.7 years

First QC Date

October 13, 2018

Last Update Submit

July 14, 2025

Conditions

Graves Ophthalmopathy

Outcome Measures

Primary Outcomes (1)

  • Reduction in periorbital fat causing improvement in proptosis

    1 year

Study Arms (2)

Bimatoprost in more proptotic eye

EXPERIMENTAL

Patients instill Bimatoprost in their more proptotic eye one nightly

Drug: Bimatoprost Ophthalmic

Control

NO INTERVENTION

Bimatoprost is not instilled in the patient's fellow eye

Interventions

Bimatoprost OphthalmicDRUG

Bimatoprost, aka Lumigan, one drop in one eye nightly

Bimatoprost in more proptotic eye

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Officials

  • Emily Li, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Li, MD

CONTACT

410-955-1112eli20@jhmi.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will evaluate clinical photos. Other measures such as Hertel's exophthalmometry values are objective outcomes which will be made available to the Principal Investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 17, 2018

Study Start

November 1, 2017

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2031

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations

US(1)