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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 Conjunctivitis

Giant 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

Page last updated: August 23, 2015

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