A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
Overview
- Phase
- Phase 4
- Intervention
- Loteprednol Etabonate
- Conditions
- Conjunctivitis, Seasonal Allergic
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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%
Investigators
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.
Arms & Interventions
Loteprednol Etabonate
Ophthalmic Gel 0.5%
Intervention: Loteprednol Etabonate
Prednisolone Acetate 1% Oph Susp
Ophthalmic suspension 0.5%
Intervention: Prednisolone Acetate 1% Oph Susp
Outcomes
Primary Outcomes
Safety
Time Frame: 4 years
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 Outcomes
- Giant Papillary Conjunctivitis(4 years)
- Seasonal Allergic Conjunctivitis(4 years)
- Post-operative inflammation(4 years)