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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-05

Study Completion Date

2015-10-19

Brief Summary

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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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Detailed Description

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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%

Conditions

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Conjunctivitis, Seasonal Allergic Conjunctivitis, Giant Papillary Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Loteprednol Etabonate

Ophthalmic Gel 0.5%

Group Type EXPERIMENTAL

Loteprednol Etabonate

Intervention Type DRUG

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

Prednisolone Acetate 1% Oph Susp

Ophthalmic suspension 0.5%

Group Type EXPERIMENTAL

Prednisolone Acetate 1% Oph Susp

Intervention Type DRUG

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

Interventions

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Loteprednol Etabonate

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

Intervention Type DRUG

Prednisolone Acetate 1% Oph Susp

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

Intervention Type DRUG

Other Intervention Names

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Lotemax Prednisolone Acetate

Eligibility Criteria

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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.