Phase 1 N=21 Randomized Quadruple-blind Treatment

Tobramycin Tear Concentrations

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT00695435 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2010

Primary outcome: Primary: Tobramycin Tear Concentration Cmax (Maximum Concentration) — 853; 527; 542 µg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: TOBRADEX Ophthalmic Suspension (Drug); Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension (Drug); TOBREX Ophthalmic Solution (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Tobramycin Tear Concentration Cmax (Maximum Concentration)	853; 527; 542	—
SECONDARY Tobramycin Tear Concentration Area Under the Curve (AUC)	6124; 2119; 2484	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00695435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.