This trial is active, not recruiting.

Conditions conjunctivitis, seasonal allergic, conjunctivitis, giant papillary, inflammation
Treatment loteprednol etabonate
Phase phase 4
Sponsor Bausch & Lomb Incorporated
Start date February 2011
End date October 2013
Trial size 690 participants
Trial identifier NCT01437982, 628


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%.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Ophthalmic suspension 0.5%
loteprednol etabonate Lotemax
Ocular administration of study drug. at least once within any indication of the label.

Primary Outcomes

time frame: 4 years

Secondary Outcomes

Seasonal Allergic Conjunctivitis
time frame: 4 years
Giant Papillary Conjunctivitis
time frame: 4 years
Post-operative inflammation
time frame: 4 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Bausch & Lomb Incorporated.