A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Conjunctivitis, Seasonal Allergic; Conjunctivitis, Giant Papillary; Inflammation
Intervention: Loteprednol Etabonate (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Bausch & Lomb Incorporated
Summary
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%.
Clinical Details
Official title: A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety
Secondary outcome: Seasonal Allergic ConjunctivitisGiant Papillary Conjunctivitis Post-operative inflammation
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Bausch & Lomb Korea Ltd, Seoul 135-280, Korea, Republic of
Additional Information
Starting date: February 2011
Last updated: November 22, 2013
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