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

Phase 4

Completed

• Conditions: Conjunctivitis, Seasonal Allergic; Conjunctivitis, Giant Papillary; Inflammation
• Interventions: Drug: Prednisolone Acetate 1% Oph Susp; Drug: Loteprednol Etabonate

• Registration Number: NCT01437982
• Lead Sponsor: Bausch & Lomb Incorporated

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%

Study Timeline

• Study Start: 2010-08-05
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Primary Completion: 2015-10-19
• Study Completion: 2015-10-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prednisolone Acetate 1% Oph Susp	Prednisolone Acetate 1% Oph Susp	Ophthalmic suspension 0.5%
Loteprednol Etabonate	Loteprednol Etabonate	Ophthalmic Gel 0.5%

Primary Outcome Measures

Name	Time	Method
Safety	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 Outcome Measures

Name	Time	Method
Giant Papillary Conjunctivitis	4 years	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.
Seasonal Allergic Conjunctivitis	4 years	Signs and symptoms of seasonal allergic conjunctivitis: The efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.
Post-operative inflammation	4 years	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.

Trial Locations

Locations (1)

Bausch & Lomb Korea Ltd; 🇰🇷 Seoul, Korea, Republic of