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

Inflammation Clinical Trial

Official title:

A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437982
• Other study ID #: 628
• Status: Completed
• Phase: Phase 4
• Start date: August 5, 2010
• Est. completion date: October 19, 2015

Study information

• Verified date: November 2019
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 19, 2015
• Est. primary completion date: October 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Conjunctivitis, Giant Papillary
• Conjunctivitis, Seasonal Allergic
• Inflammation

Intervention

Drug:
• Loteprednol Etabonate
Ocular administration of study drug. at least once within any indication of the label.
• Prednisolone Acetate 1% Oph Susp
Ocular administration of study drug. at least once within any indication of the label.

Locations

Country	Name	City	State
Korea, Republic of	Bausch & Lomb Korea Ltd	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years
Secondary	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.	4 years
Secondary	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.	4 years
Secondary	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.	4 years