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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-15

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension

NCT00576251

Ocular Inflammation Associated With Blepharaconjunctivitis

COMPLETED PHASE3

Zylet vs TobraDex in Blepharokeratoconjunctivitis

NCT00447577

Blepharokeratoconjunctivitis

COMPLETED PHASE4

Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

NCT01028027

Conjunctivitis Keratitis Blepharitis

COMPLETED PHASE3

Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis

NCT01227915

Acute Bacterial Conjunctivitis

UNKNOWN PHASE3

Tobramycin Tear Concentrations

NCT00695435

Dry Eye

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blepharo Conjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 .

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Tobramycin/dexamethasone opthalmic solution

Intervention Type DRUG

To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution

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

Group Type ACTIVE_COMPARATOR

Tobradex Opthalmic Solution

Intervention Type DRUG

Tobradex Opthalmic Solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tobramycin/dexamethasone opthalmic solution

To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution

Intervention Type DRUG

Tobradex Opthalmic Solution

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tobradex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No