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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobramycin/Dexamethasone opthamic Solution | Experimental | This group of randomized patients will be instructed to instill 2 gtt of Tobramycin/Dexamethasone opthamic solution every 6 hours for 10 days |
|
| Tobradex Opthalmic Solution | Active Comparator | This group of randomized patients will be instructed to instill 2 gtt of Tobradex Opthalmic Solution every 6 hours for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin/dexamethasone opthalmic solution | Drug | To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajai Prakash | Contact | 7183260310 | ajaiprakashny@gmail.com | |
| Jayesh R patel | Contact | 5166414687 | jaysheela@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Ajai Prakash | Sutphin Drugs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutphin Drugs | Jamaica | New York | 11435 | United States |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| D000078162 | Tobramycin, Dexamethasone Drug Combination |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
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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 .
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|
| Tobradex Opthalmic Solution | Drug | Tobradex Opthalmic Solution |
|
| Carbohydrates |
| D003907 | Dexamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |