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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01437982

Enrollment

140

Registered

2011-09-21

Start date

2010-08-05

Completion date

2015-10-19

Last updated

2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conjunctivitis, Seasonal Allergic, Conjunctivitis, Giant Papillary, Inflammation

Keywords

post-operative inflammation, conjunctivitis, safety, Seasonal allergic conjunctivitis, Giant papillary conjunctivitis

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%

Interventions

DRUGLoteprednol Etabonate

Ocular administration of study drug. at least once within any indication of the label.

DRUGPrednisolone Acetate 1% Oph Susp

Ocular administration of study drug. at least once within any indication of the label.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026