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Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02155049
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Maya Eiger, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE May 21, 2014
First Posted Date  ICMJE June 4, 2014
Last Update Posted Date February 19, 2018
Study Start Date  ICMJE November 2014
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients. [ Time Frame: 6 months ]
To document the effect of bimatoprost treatment on the amount of soft tissue and exophthalmos in inactive TED patients. The following measurements will be performed pre, post and during treatment: orbital ultrasound (measuring the eyebrow fat, retro-orbicularis oculi fat and retrobulbar fat), Hertel exophthalmometry and Marginal Reflex Distance (MRD). The external appearance would be also documented by face picture.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02155049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
Number of participants with adverse events. [ Time Frame: 9 months ]
Determine the safety of bimatoprost treatment by estimating the probabilities of adverse outcomes. To estimate these probabilities we shall count the number of participants suffering from known side-effects of prostaglandin analogues such as increased eyelash growth and darkening of the periocular skin and iris; as well as any other side-effects observed during treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 3, 2014)
Bimatoprost effect reversibility after treatment cessation. [ Time Frame: 3 months ]
To measure the reversibility of bimatoprost treatment on the amount of soft tissue and exophthalmos at the end of the treatment course and 3 months post cessation. We shall perform the same measurements as described in the Primary Outcome section.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues
Official Title  ICMJE Phase 3 Study of Treatment of Soft Tissue Expansion and Exophthalmos in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues.
Brief Summary Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Associated Ophthalmopathies
Intervention  ICMJE Drug: bimatoprost 0.03%
The patients will receive a single daily drop of bimatoprost for six months.
Other Name: Lumigan (Allergan, Inc, Irvine, California)
Study Arms  ICMJE Experimental: Prostaglandin Analogues
The patients will receive a single daily drop of bimatoprost for six months.
Intervention: Drug: bimatoprost 0.03%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2014)
20
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Inactive TED (Clinical Activity Score below 3)
  • Significant exophthalmos or orbital fat expansion.

Exclusion Criteria:

  • Previous prostaglandin analogues treatment due to glaucoma
  • Known prostaglandin analogues sensitivity.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02155049
Other Study ID Numbers  ICMJE TED-01
Thyroid eye disease ( Registry Identifier: Prostaglandin Analogues )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maya Eiger, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maya Eiger, MD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP