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

November 18, 2019 updated by: Bausch & Lomb Incorporated

A Post Marketing Surveillance 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Loteprednol Etabonate
Ophthalmic Gel 0.5%
Drug: Loteprednol Etabonate
Ocular administration of study drug. at least once within any indication of the label.
Other Names:
  • Lotemax
Experimental: Prednisolone Acetate 1% Oph Susp
Ophthalmic suspension 0.5%
Drug: Prednisolone Acetate 1% Oph Susp
Ocular administration of study drug. at least once within any indication of the label.
Other Names:
  • Prednisolone Acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years
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.
4 years
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Binu Alexander, MD, Valeant Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2010

Primary Completion (Actual)

October 19, 2015

Study Completion (Actual)

October 19, 2015

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (Estimate)

September 21, 2011

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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