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

Primary Purpose

Blepharo Conjunctivitis

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tobramycin/dexamethasone opthalmic solution
Tobradex Opthalmic Solution
Sponsored by
Sutphin Drugs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharo Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sutphin Drugs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tobramycin/Dexamethasone opthamic Solution

Tobradex Opthalmic Solution

Arm Description

This group of randomized patients will be instructed to instill 2 gtt of Tobramycin/Dexamethasone opthamic solution every 6 hours for 10 days

This group of randomized patients will be instructed to instill 2 gtt of Tobradex Opthalmic Solution every 6 hours for 10 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2019
Last Updated
June 4, 2019
Sponsor
Sutphin Drugs
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1. Study Identification

Unique Protocol Identification Number
NCT03975374
Brief Title
To Study Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
Official Title
Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2019 (Anticipated)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sutphin Drugs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharo Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tobramycin/Dexamethasone opthamic Solution
Arm Type
Experimental
Arm Description
This group of randomized patients will be instructed to instill 2 gtt of Tobramycin/Dexamethasone opthamic solution every 6 hours for 10 days
Arm Title
Tobradex Opthalmic Solution
Arm Type
Active Comparator
Arm Description
This group of randomized patients will be instructed to instill 2 gtt of Tobradex Opthalmic Solution every 6 hours for 10 days
Intervention Type
Drug
Intervention Name(s)
Tobramycin/dexamethasone opthalmic solution
Other Intervention Name(s)
Tobradex
Intervention Description
To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution
Intervention Type
Drug
Intervention Name(s)
Tobradex Opthalmic Solution
Intervention Description
Tobradex Opthalmic Solution
Primary Outcome Measure Information:
Title
Sign and symptoms composite score
Description
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.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ajai Prakash
Phone
7183260310
Email
ajaiprakashny@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jayesh R patel
Phone
5166414687
Email
jaysheela@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajai Prakash
Organizational Affiliation
Sutphin Drugs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutphin Drugs
City
Jamaica
State/Province
New York
ZIP/Postal Code
11435
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajai Prakash, PhD
Phone
718-326-0310
Email
ajaiprakashny@gmail.com
First Name & Middle Initial & Last Name & Degree
Jayesh Patel
Phone
5166414687
Email
healingathome13@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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