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Tobramycin Tear Concentrations

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TOBRADEX Ophthalmic Suspension
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
TOBREX Ophthalmic Solution
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring normal volunteers, anti-infective, tobramycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Contact Alcon Call Center For Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

TOBREX® Ophthalmic Solution

TOBRADEX® Ophthalmic Suspension

Arm Description

Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension

TOBREX® Ophthalmic Solution

TOBRADEX® Ophthalmic Suspension

Outcomes

Primary Outcome Measures

Tobramycin Tear Concentration Cmax (Maximum Concentration)
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 Outcome Measures

Tobramycin Tear Concentration Area Under the Curve (AUC)
Trapezoidal AUC was calculated from 2 to 18 minutes.

Full Information

First Posted
June 9, 2008
Last Updated
February 23, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00695435
Brief Title
Tobramycin Tear Concentrations
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
normal volunteers, anti-infective, tobramycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
Arm Type
Experimental
Arm Description
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
Arm Title
TOBREX® Ophthalmic Solution
Arm Type
Active Comparator
Arm Description
TOBREX® Ophthalmic Solution
Arm Title
TOBRADEX® Ophthalmic Suspension
Arm Type
Active Comparator
Arm Description
TOBRADEX® Ophthalmic Suspension
Intervention Type
Drug
Intervention Name(s)
TOBRADEX Ophthalmic Suspension
Intervention Description
TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline
Intervention Type
Drug
Intervention Name(s)
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
Intervention Description
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline
Intervention Type
Drug
Intervention Name(s)
TOBREX Ophthalmic Solution
Intervention Description
TOBREX Ophthalmic Solution 1 drop each eye at baseline
Primary Outcome Measure Information:
Title
Tobramycin Tear Concentration Cmax (Maximum Concentration)
Description
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.
Time Frame
2, 4, 6, 12, and 18 minutes
Secondary Outcome Measure Information:
Title
Tobramycin Tear Concentration Area Under the Curve (AUC)
Description
Trapezoidal AUC was calculated from 2 to 18 minutes.
Time Frame
2 to 18 minutes post administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy 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.
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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