3 Participants Needed

Bimatoprost for Graves' Eye Disease

EL
EG
Overseen ByErin Godbout, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking steroids.

Is bimatoprost generally safe for human use?

Bimatoprost, used in treatments like Lumigan and Latisse, is generally well tolerated, but some people may experience side effects like mild eye redness, eyelash growth, and itching. There is also a small risk of changes in fat around the eyes, which can be permanent, so it's important to discuss these potential side effects with your doctor.12345

How is the drug bimatoprost unique for treating Graves' Eye Disease?

Bimatoprost is unique because it is a synthetic prostamide that lowers eye pressure by increasing fluid outflow, and it is typically used for glaucoma and ocular hypertension. Its use in Graves' Eye Disease is novel, as it may offer a new approach by leveraging its pressure-lowering effects, which are not standard for this condition.12456

What is the purpose of this trial?

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

Research Team

EL

Emily Li, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals with Graves' Eye Disease who are experiencing bulging eyes (Exophthalmos/Proptosis). Participants should not have active Graves' disease, be pregnant, or be taking steroids.

Inclusion Criteria

I have bulging eyes due to thyroid eye disease.

Exclusion Criteria

I have active Graves' disease.
I am currently taking steroids.
Currently pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants instill Bimatoprost in their more proptotic eye nightly

8 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Bimatoprost Ophthalmic
Trial Overview The study is examining if Bimatoprost eye drops, commonly used for glaucoma, can help reduce the swelling around the eyes in patients with Graves' Orbitopathy by causing fat loss in that area.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Bimatoprost in more proptotic eyeExperimental Treatment1 Intervention
Patients instill Bimatoprost in their more proptotic eye one nightly
Group II: ControlActive Control1 Intervention
Bimatoprost is not instilled in the patient's fellow eye

Bimatoprost Ophthalmic is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Lumigan for:
  • Open-angle glaucoma
  • Ocular hypertension
  • Eyelash hypotrichosis
🇪🇺
Approved in European Union as Lumigan for:
  • Open-angle glaucoma
  • Ocular hypertension
🇺🇸
Approved in United States as Latisse for:
  • Eyelash hypotrichosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Findings from Research

In a study of 6,767 patients with glaucoma or ocular hypertension, bimatoprost 0.03% monotherapy significantly lowered intraocular pressure (IOP) by an average of 7.5 mmHg (30%) after 2 months, demonstrating its efficacy in untreated patients.
Bimatoprost was well tolerated, with 41.5% of patients achieving target IOPs of ≤15 mmHg and 75.8% reaching ≤18 mmHg, although the most common side effect reported was conjunctival hyperemia (7.9%).
Efficacy of bimatoprost 0.03 percent in untreated glaucoma and ocular hypertension patients: results from a large community-based clinical trial.Quinones, R., Severin, T., Mundorf, T.[2015]
The bimatoprost implant (Durysta™) is a biodegradable drug delivery system that provides sustained release of bimatoprost to lower intraocular pressure (IOP) for 4 to 6 months, making it a convenient treatment option for patients with open angle glaucoma or ocular hypertension.
Approved in March 2020, the implant represents a significant advancement in glaucoma treatment, allowing for prolonged IOP control without the need for daily eye drops, and its clinical development is still ongoing.
Bimatoprost Implant: First Approval.Shirley, M.[2020]
Bimatoprost 0.03%, used for treating hypotrichosis and glaucoma, can cause significant periocular fat atrophy, leading to hollowing around the eyes in some patients, as observed in a retrospective review of 7 cases.
Both cosmetic (Latisse) and ophthalmic (Lumigan) formulations of bimatoprost are identical, so patients should be warned about the risk of irreversible fat changes, highlighting the need for careful consideration before prescribing.
Topical bimatoprost 0.03% and iatrogenic eyelid and orbital lipodystrophy.Sira, M., Verity, DH., Malhotra, R.[2016]

References

Efficacy of bimatoprost 0.03 percent in untreated glaucoma and ocular hypertension patients: results from a large community-based clinical trial. [2015]
Bimatoprost Implant: First Approval. [2020]
Topical bimatoprost 0.03% and iatrogenic eyelid and orbital lipodystrophy. [2016]
Bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension. [2021]
Clinical pharmacology of bimatoprost. [2019]
Periorbital changes associated with topical bimatoprost. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security