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

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT01437982

Collaborator

(none)

140

Enrollment

Location

Arms

62.5

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis, Seasonal Allergic Conjunctivitis, Giant Papillary Inflammation	Drug: Loteprednol Etabonate Drug: Prednisolone Acetate 1% Oph Susp	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 5, 2010

Actual Primary Completion Date :

Oct 19, 2015

Actual Study Completion Date :

Oct 19, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.