Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation
This study is ongoing, but not recruiting participants.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01736527
First received: November 27, 2012
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug Level in Tear Fluid |
Drug: LE Gel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% at 6, 9, 12, and 24 Hours Following a Single Instillation in Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Tear fluid levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | April 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: LE Gel
Single drop of LE Gel 0.5% administered to the study eye on visit 2
Other Name: Lotemax
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736527
Locations
| United States, New York | |
| Bausch & Lomb Research Clinic | |
| Rochester, New York, United States, 14609 | |
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Principal Investigator: | Jeffery Schafer, OD, MS | Bausch & Lomb Incorporated |
| Study Director: | Raphaele Siou Mermet, MD, MS | Bausch & Lomb Incorporated |
More Information
No publications provided
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT01736527 History of Changes |
| Other Study ID Numbers: | 808 |
| Study First Received: | November 27, 2012 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Loteprednol etabonate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013