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

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ClinicalTrials.gov Identifier: NCT03975374
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ajai Prakash, Sutphin Drugs

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

Condition or disease Intervention/treatment Phase
Blepharo Conjunctivitis Drug: Tobramycin/dexamethasone opthalmic solution Drug: Tobradex Opthalmic Solution Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Experimental: Tobramycin/Dexamethasone opthamic Solution
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
To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution
Other Name: Tobradex

Active Comparator: Tobradex Opthalmic Solution
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
Tobradex Opthalmic Solution




Primary Outcome Measures :
  1. Sign and symptoms composite score [ Time Frame: 10 days ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975374


Contacts
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Contact: Ajai Prakash 7183260310 ajaiprakashny@gmail.com
Contact: Jayesh R patel 5166414687 jaysheela@aol.com

Locations
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United States, New York
Sutphin Drugs Recruiting
Jamaica, New York, United States, 11435
Contact: Ajai Prakash, PhD    718-326-0310    ajaiprakashny@gmail.com   
Contact: Jayesh Patel    5166414687    healingathome13@gmail.com   
Sponsors and Collaborators
Sutphin Drugs
Investigators
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Principal Investigator: Ajai Prakash Sutphin Drugs

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Responsible Party: Dr. Ajai Prakash, President, Sutphin Drugs
ClinicalTrials.gov Identifier: NCT03975374     History of Changes
Other Study ID Numbers: Sutphin T
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Conjunctivitis
Conjunctival Diseases
Eye Diseases
Tobramycin
Tobramycin, Dexamethasone Drug Combination
Dexamethasone
Dexamethasone acetate
Ophthalmic Solutions
Pharmaceutical Solutions
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents