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A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%

This study is currently recruiting participants.
Verified December 2012 by Bausch & Lomb Incorporated
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01437982
First received: September 20, 2011
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice after marketing authorization of Lotemax ophthalmic suspension 0.5%.


Condition Intervention Phase
Conjunctivitis, Seasonal Allergic
Conjunctivitis, Giant Papillary
Inflammation
 Drug: Loteprednol Etabonate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Safety [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    All adverse events that occurred from the first dose of the study drug regardless of causality to the study drug. Changes in all undesirable medical findings and all adverse events occurring with the use of the study drug.


Secondary Outcome Measures:
  • Seasonal Allergic Conjunctivitis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Signs and symptoms of seasonal allergic conjunctivitis: The efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.

  • Giant Papillary Conjunctivitis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Signs and symptoms of giant papillary conjunctivitis: The results of the efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.

  • Post-operative inflammation [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Treatment of post-operative inflammation following ocular surgery: The results of the final efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.


Estimated Enrollment: 690
Study Start Date: February 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Loteprednol Etabonate
Ophthalmic suspension 0.5%
 Drug: Loteprednol Etabonate
Ocular administration of study drug. at least once within any indication of the label.
Other Name: Lotemax

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have been treated with the study drug at least once and completed safety follow-up.
  • Subjects who have been treated with the study drug at least once and completed the clinical efficacy assessment.

Exclusion Criteria:

  • Subjects not treated with study drug at least once.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437982

Contacts
Contact: Esther Chu +65 6490-5856 esther.chu@bausch.com

Locations
Korea, Republic of
Bausch & Lomb Korea Ltd Recruiting
Seoul, Korea, Republic of, 135-280
Contact: Esther Chu         esther.chu@bausch.com    
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01437982     History of Changes
Other Study ID Numbers: 628
Study First Received: September 20, 2011
Last Updated: December 20, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
post-operative inflammation
conjunctivitis
safety
Seasonal allergic conjunctivitis
Giant papillary conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Inflammation
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Pathologic Processes
Loteprednol etabonate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013