To Study Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to compare and describe efficacy and safety of Tobradex ophthalmic suspension versus generic Tobramycin/dexamethasone Suspension in treatment of Blepharoconjuctivitis through clinical parameters

Detailed Description
-----------------
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter; Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.

Official Title
-----------------
Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension

Conditions
-----------------
Blepharo Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Tobramycin/dexamethasone opthalmic solution
* Drug: Tobradex Opthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All potential subjects with symptomatic blepharitis examined to have blepharitis with healthy mental status, able to give consent, with/without co-existing medical conditions will be considered Exclusion Criteria: All subjects with history and/or probable history of allergic reaction to tobramycin/dexamethasone and all subjects who have mental disability and are unable to give direct consent will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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: Parallel Assignment
Interventional Model Description: In group one, patients will be instructed to instill 2 gtt of Tobradex ophthalmic solution for 10 days. In group two, patients will be instructed to instill 2 gtt of Tobramycin/dexamethasone solution for 10 days .
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tobramycin/Dexamethasone opthamic Solution<br>This group of randomized patients will be instructed to instill 2 gtt of Tobramycin/Dexamethasone opthamic solution every 6 hours for 10 days | Drug: Tobramycin/dexamethasone opthalmic solution<br>* To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution<br>* Other names: Tobradex;|
| Active Comparator: Tobradex Opthalmic Solution<br>This group of randomized patients will be instructed to instill 2 gtt of Tobradex Opthalmic Solution every 6 hours for 10 days | Drug: Tobradex Opthalmic Solution<br>* Tobradex Opthalmic Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sign and symptoms composite score | The change from baseline in the signs and symptoms score. Global sign and symptom score defined as the total score of lid margin redness (0-3), lid swelling (0-4), bulbar conjunctival redness (0-3), palpebral conjunctival redness (0-3), ocular discharge (0-3), itchy eyelids (0-4), and gritty eyes (0-4). The change from baseline to Day 10 (Visit 3 at day 1, day 7 and day 10) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. | 10 days |