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

Bausch + Lomb

Status and phase: Completed; Phase 4

Conditions: Inflammation; Conjunctivitis, Giant Papillary; Conjunctivitis, Seasonal Allergic

Treatments: Drug: Prednisolone Acetate 1% Oph Susp; Drug: Loteprednol Etabonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437982

628

Details and patient eligibility

About

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

Full 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%

Enrollment: 140 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Loteprednol Etabonate

Experimental group

Description:

Ophthalmic Gel 0.5%

Treatment:

Drug: Loteprednol Etabonate

Prednisolone Acetate 1% Oph Susp

Experimental group

Description:

Ophthalmic suspension 0.5%

Treatment:

Drug: Prednisolone Acetate 1% Oph Susp