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OpenTrials
Completed

NCT Number: NCT00695435

Tobramycin Tear Concentrations

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TOBRADEX Ophthalmic Suspension

Drug

TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

Drug

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

TOBREX Ophthalmic Solution

Drug

TOBREX Ophthalmic Solution 1 drop each eye at baseline

Primary outcomes

  1. Tobramycin Tear Concentration Cmax (Maximum Concentration)

    Time frame: 2, 4, 6, 12, and 18 minutes

    Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period.

Secondary outcomes

  1. Tobramycin Tear Concentration Area Under the Curve (AUC)

    Time frame: 2 to 18 minutes post administration

    Trapezoidal AUC was calculated from 2 to 18 minutes.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
First posted
Jun 11, 2008
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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