Tobramycin Tear Concentrations

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alcon Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ophthalmic Solutions; Pharmaceutical Solutions; Tobramycin; Tobramycin, Dexamethasone Drug Combination

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.