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

Study Overview
=================
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

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%

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

Conditions
-----------------
Conjunctivitis, Seasonal Allergic, Conjunctivitis, Giant Papillary, Inflammation

Intervention / Treatment
-----------------
* Drug: Loteprednol Etabonate
* Drug: Prednisolone Acetate 1% Oph Susp


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol Etabonate<br>Ophthalmic Gel 0.5% | Drug: Loteprednol Etabonate<br>* Ocular administration of study drug. at least once within any indication of the label.<br>* Other names: Lotemax;|
| Experimental: Prednisolone Acetate 1% Oph Susp<br>Ophthalmic suspension 0.5% | Drug: Prednisolone Acetate 1% Oph Susp<br>* Ocular administration of study drug. at least once within any indication of the label.<br>* Other names: Prednisolone Acetate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative inflammation, conjunctivitis, safety, Seasonal allergic conjunctivitis, Giant papillary conjunctivitis