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Intralesional Tetracycline Injection in the Treatment of Chalazia (TET)

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ClinicalTrials.gov Identifier: NCT01763437
Recruitment Status : Withdrawn (Investigator left the institution)
First Posted : January 8, 2013
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chalazia Chalazion Drug: Tetracycline Early Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intralesional Tetracycline Injection in the Treatment of Chalazia
Study Start Date : March 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Lesion size [ Time Frame: 4 weeks ]
    The size of the lesion will be measured as well as photographed. Photographs will be reviewed by a masked chalazion photograph reviewer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763437


Locations
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United States, Ohio
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, United States, 44145
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Julian D Perry, M.D. Cleveland Clinic Cole Eye Institute
More Information
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Publications of Results:
Lacy CF, Armstrong LL, Goldman, MP, Lance LL. Lexi-Comp's Drug Information Handbook. 13th ed. 2005. 1447.
Wolff K, Johnson RA, et al. Fitzpatrick's Color Atlas & Synopsis of Clinical Dermatology. 5th ed. McGraw-Hill. 2005.
Macquire JI, Murchinson AP, et al. Wills Eye Institute 5-minute Ophthalmology Consult. Lippencott Williams & Wilkins.

Other Publications:

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01763437     History of Changes
Other Study ID Numbers: TET2013
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Keywords provided by The Cleveland Clinic:
Chalazia
Chalazion
Meibomian gland dysfunction
Rosacea
Ocular rosacea
Additional relevant MeSH terms:
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Chalazion
Cysts
Neoplasms
Eyelid Diseases
Eye Diseases
Tetracycline
 Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action