Intralesional Tetracycline Injection in the Treatment of Chalazia (TET)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01763437
First received: January 5, 2013
Last updated: December 11, 2013
Last verified: January 2013
  Purpose

The investigators propose a study to investigate the role of tetracycline injection into chalazia versus observation alone. The investigators hypothesize tetracycline injection will result in a significant decrease in lesion size when compared to observation alone.


Condition Intervention Phase
Chalazia
Chalazion
Drug: Tetracycline
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intralesional Tetracycline Injection in the Treatment of Chalazia

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Lesion size [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The size of the lesion will be measured as well as photographed. Photographs will be reviewed by a masked chalazion photograph reviewer.


Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation
30 patients will be randomized to observation alone. These patients will return 4 weeks (+/- 2 weeks) after their initial visit for lesion measurement and photographs.
Experimental: Tetracycline
30 patients will be randomized to treatment with an intralesional injection of 0.05 mL of 2% tetracycline solution. These subjects will return 4 weeks (+/- 2 weeks) after treatment for lesion measurement and photographs.
Drug: Tetracycline
Chalazia randomized to the treatment arm will be injected with 0.05 mL of 2% tetracycline solution.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age older than 18 years
  • Not pregnant
  • Chalazia of greater than 1 week duration
  • Not allergic to tetracycline or its derivatives
  • Not currently taking tetracycline or not taking them in the past 3 months

Exclusion Criteria:

  • Age less than 18 years old
  • Pregnancy
  • Chalazia of less than 1 week duration
  • Allergies to tetracycline or its derivatives
  • Currently taking tetracyclines or have taken them in the past 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763437

Contacts
Contact: Julian D Perry, M.D. 216 444 3635 perryj1@ccf.org

Locations
United States, Ohio
Cleveland Clinic Cole Eye Institute Not yet recruiting
Cleveland, Ohio, United States, 44145
Contact: Laura Holody       holodyl@ccf.org   
Principal Investigator: Julian D Perry, M.D.         
Sub-Investigator: Bryan R Costin, M.D.         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Julian D Perry, M.D. Cleveland Clinic Cole Eye Institute
  More Information

Publications:

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01763437     History of Changes
Other Study ID Numbers: TET2013
Study First Received: January 5, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Chalazia
Chalazion
Meibomian gland dysfunction
Rosacea
Ocular rosacea

Additional relevant MeSH terms:
Chalazion
Cysts
Neoplasms
Eyelid Diseases
Eye Diseases
Tetracycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014