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Tobramycin Tear Concentrations

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dry Eye

Intervention: TOBRADEX Ophthalmic Suspension (Drug); Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension (Drug); TOBREX Ophthalmic Solution (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Alcon Research

Summary

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.

Clinical Details

Official title: Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Tobramycin Tear Concentration Cmax (Maximum Concentration)

Secondary outcome: Tobramycin Tear Concentration Area Under the Curve (AUC)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion:

- 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.

Locations and Contacts

Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States
Additional Information

Starting date: June 2008
Last updated: February 23, 2010

Page last updated: August 23, 2015

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