Dry Eye
Conditions
Keywords
normal volunteers, anti-infective, tobramycin
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.
Interventions
DRUGTOBRADEX Ophthalmic Suspension
TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline
DRUGTobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline
DRUGTOBREX Ophthalmic Solution
TOBREX Ophthalmic Solution 1 drop each eye at baseline
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobramycin Tear Concentration Cmax (Maximum Concentration) | 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
| Measure | Time frame | Description |
|---|---|---|
| Tobramycin Tear Concentration Area Under the Curve (AUC) | 2 to 18 minutes post administration | Trapezoidal AUC was calculated from 2 to 18 minutes. |
Countries
United States
Participant flow
Recruitment details
Randomized, single center (Alcon Eye Clinic),
Pre-assignment details
Treatment randomization schedules were generated and maintained by the Alcon SAS Programming group. Only when the data were verified and validated and the database locked were the appropriate personnel unmasked.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Overall Study | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 | 2 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 21 |
Outcome results
Primary
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.
Time frame: 2, 4, 6, 12, and 18 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | Tobramycin Tear Concentration Cmax (Maximum Concentration) | 853 µg/mL | Standard Deviation 618 |
| TOBREX® Ophthalmic Solution | Tobramycin Tear Concentration Cmax (Maximum Concentration) | 527 µg/mL | Standard Deviation 428 |
| TOBRADEX® Ophthalmic Suspension | Tobramycin Tear Concentration Cmax (Maximum Concentration) | 542 µg/mL | Standard Deviation 425 |
Secondary
Tobramycin Tear Concentration Area Under the Curve (AUC)
Trapezoidal AUC was calculated from 2 to 18 minutes.
Time frame: 2 to 18 minutes post administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | Tobramycin Tear Concentration Area Under the Curve (AUC) | 6124 min*ug/mL | Standard Deviation 4776 |
| TOBREX® Ophthalmic Solution | Tobramycin Tear Concentration Area Under the Curve (AUC) | 2119 min*ug/mL | Standard Deviation 1820 |
| TOBRADEX® Ophthalmic Suspension | Tobramycin Tear Concentration Area Under the Curve (AUC) | 2484 min*ug/mL | Standard Deviation 2182 |