Tobramycin Tear Concentrations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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

To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.

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

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

NCT03975374

Blepharo Conjunctivitis

UNKNOWN EARLY_PHASE1

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

Zylet vs TobraDex in Blepharokeratoconjunctivitis

NCT00447577

Blepharokeratoconjunctivitis

COMPLETED PHASE4

Detailed Description

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

Conditions

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

Dry Eye

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

Group Type EXPERIMENTAL

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

Intervention Type DRUG

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline

TOBREX® Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

TOBREX Ophthalmic Solution

Intervention Type DRUG

TOBREX Ophthalmic Solution 1 drop each eye at baseline

TOBRADEX® Ophthalmic Suspension

Group Type ACTIVE_COMPARATOR

TOBRADEX Ophthalmic Suspension

Intervention Type DRUG

TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline

Interventions

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

TOBRADEX Ophthalmic Suspension

TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline

Intervention Type DRUG

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline

Intervention Type DRUG

TOBREX Ophthalmic Solution

TOBREX Ophthalmic Solution 1 drop each eye at baseline

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Visual Acuity (VA) of 0.6 logMAR or better
* Tear meniscus height of ≥ 0.3mm at Visit 1.
* No concomitant topical ocular medications, including artificial tears, during the study period

Exclusion

* ocular hypertension, iritis or uveitis, glaucoma
* ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
* epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
* lacrimal duct obstruction, dry eye, ocular allergies.
* contact lens within 7 days of Visit 1.
* ocular medications within 14 days of Visit 1.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes