Tobramycin Tear Concentrations

Alcon

Status and phase: Completed; Phase 1

Conditions: Dry Eye

Treatments: Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension; Drug: TOBREX Ophthalmic Solution; Drug: TOBRADEX Ophthalmic Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00695435

C-08-33

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

21 participants in 3 patient groups

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

Experimental group

Description:

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

Treatment:

Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

TOBREX® Ophthalmic Solution

Active Comparator group

Description:

TOBREX® Ophthalmic Solution

Treatment:

Drug: TOBREX Ophthalmic Solution

TOBRADEX® Ophthalmic Suspension

Active Comparator group

Description:

TOBRADEX® Ophthalmic Suspension

Treatment:

Drug: TOBRADEX Ophthalmic Suspension