Pharmacokinetics
Conditions
Brief summary
To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.
Interventions
DRUGLE Gel
Single drop of LE Gel 0.5% administered to the study eye on visit 2
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * Subjects must have a best-corrected visual acuity of 20/20 or better in each eye. * Subjects must have no active ocular disease or allergic conjunctivitis. * Subjects must have a Schirmer test (without anesthesia) of ≥ 10mm in 5 minutes. * Subjects must not be using any topical ocular medications or systemic medication other than acetaminophen. * Male subjects or female subjects who are not of childbearing potential. Female subjects are considered to not be of childbearing potential if they are postmenopausal for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
Exclusion criteria
* Subjects having an intraocular pressure less than 5 mmHg or greater than 22 mmHg or any type of glaucoma. * Subjects with a history of ocular trauma, infection, or inflammation within the last 3 months. * Subjects having any contraindication to the use of, or known sensitivity or allergy to, the study drug(s) or their components. * Subjects wearing contact lenses on the day of Visit 2 and/or Visit 3 of the study * Subjects having, at the Investigator's discretion, the presence of any significant illness that could be expected to interfere with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Fluid Levels | 6 hours | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose |
Countries
United States
Participant flow
Recruitment details
Single center, open label, single dose study in healthy volunteers. First participant enrolled 01/08/2013, last participant exited: 01/18/2013.
Pre-assignment details
A total of 17 participants were screened for this study. Of those screened, 12 participants were included to receive treatment; these subjects constituted the Safety population. No participants discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| LE Gel A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | LE Gel |
|---|---|
| Age, Customized | 45.6 years STANDARD_DEVIATION 11.37 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Tear Fluid Levels
Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose
Time frame: 6 hours
Population: The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LE Gel | Tear Fluid Levels | 113.633 μg/g | Standard Deviation 116.0133 |
Primary
Tear Fluid Levels
Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose
Time frame: 9 hours
Population: The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LE Gel | Tear Fluid Levels | 19.667 μg/g | Standard Deviation 18.1625 |
Primary
Tear Fluid Levels
Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose
Time frame: 12 hours
Population: The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LE Gel | Tear Fluid Levels | 26.877 μg/g | Standard Deviation 29.6464 |
Primary
Tear Fluid Levels
Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose
Time frame: 24 hours
Population: The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LE Gel | Tear Fluid Levels | 2.408 μg/g | Standard Deviation 3.3631 |