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Intralesional Tetracycline Injection in the Treatment of Chalazia (TET)

This study is not yet open for participant recruitment.
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: January 9, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Rosacea
U.S. FDA Resources

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 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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
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: January 9, 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
Protein Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013