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

Sutphin Drugs

Status and phase: Unknown; Early Phase 1

Conditions: Blepharo Conjunctivitis

Treatments: Drug: Tobradex Opthalmic Solution; Drug: Tobramycin/dexamethasone opthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03975374

Sutphin T

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,000 participants in 2 patient groups

Tobramycin/Dexamethasone opthamic Solution

Experimental group

Description:

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

Treatment:

Drug: Tobramycin/dexamethasone opthalmic solution

Tobradex Opthalmic Solution

Active Comparator group

Description:

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

Treatment:

Drug: Tobradex Opthalmic Solution