Back to resultsA Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
Primary Purpose
Conjunctivitis, Seasonal Allergic, Conjunctivitis, Giant Papillary, Inflammation
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Loteprednol Etabonate
Prednisolone Acetate 1% Oph Susp
Sponsored by
About this trial
This is an interventional treatment trial for Conjunctivitis, Seasonal Allergic focused on measuring post-operative inflammation, conjunctivitis, safety, Seasonal allergic conjunctivitis, Giant papillary conjunctivitis
Eligibility 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.
Sites / Locations
- Bausch & Lomb Korea Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Loteprednol Etabonate
Prednisolone Acetate 1% Oph Susp
Arm Description
Ophthalmic Gel 0.5%
Ophthalmic suspension 0.5%
Outcomes
Primary Outcome Measures
Safety
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
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
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
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.
Full Information
NCT ID
NCT01437982
First Posted
September 20, 2011
Last Updated
November 18, 2019
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01437982
Brief Title
A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
Official Title
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 5, 2010 (Actual)
Primary Completion Date
October 19, 2015 (Actual)
Study Completion Date
October 19, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice
Detailed Description
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%
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Seasonal Allergic, Conjunctivitis, Giant Papillary, Inflammation
Keywords
post-operative inflammation, conjunctivitis, safety, Seasonal allergic conjunctivitis, Giant papillary conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Loteprednol Etabonate
Arm Type
Experimental
Arm Description
Ophthalmic Gel 0.5%
Arm Title
Prednisolone Acetate 1% Oph Susp
Arm Type
Experimental
Arm Description
Ophthalmic suspension 0.5%
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate
Other Intervention Name(s)
Lotemax
Intervention Description
Ocular administration of study drug. at least once within any indication of the label.
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate 1% Oph Susp
Other Intervention Name(s)
Prednisolone Acetate
Intervention Description
Ocular administration of study drug. at least once within any indication of the label.
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Seasonal Allergic Conjunctivitis
Description
Signs and symptoms of seasonal allergic conjunctivitis: The efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.
Time Frame
4 years
Title
Giant Papillary Conjunctivitis
Description
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.
Time Frame
4 years
Title
Post-operative inflammation
Description
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.
Time Frame
4 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binu Alexander, MD
Organizational Affiliation
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Korea Ltd
City
Seoul
ZIP/Postal Code
135-280
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
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