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

Blepharo Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03975374
• Other study ID #: Sutphin T
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 15, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2019
• Source: Sutphin Drugs
• Contact: Ajai Prakash
• Phone: 7183260310
• Email: ajaiprakashny[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: June 30, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharo Conjunctivitis
• Conjunctivitis

Intervention

Drug:
• Tobramycin/dexamethasone opthalmic solution
To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution
• Tobradex Opthalmic Solution
Tobradex Opthalmic Solution

Locations

Country	Name	City	State
United States	Sutphin Drugs	Jamaica	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sutphin Drugs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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