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Completed

NCT Number: NCT01437982

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

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

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Key information

Conditions

Conjunctivitis, Seasonal Allergic Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Conjunctivitis, Giant Papillary Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bausch & Lomb Korea Ltd

Seoul, 135-280, South Korea

About this study

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%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Loteprednol Etabonate

Drug

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

Other names: Lotemax

Prednisolone Acetate 1% Oph Susp

Drug

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

Other names: Prednisolone Acetate

Primary outcomes

  1. 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

  1. Seasonal Allergic Conjunctivitis

    Time frame: 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.

  2. Giant Papillary Conjunctivitis

    Time frame: 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.

  3. Post-operative inflammation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2011
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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