NCT01736527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 8, 2013

Completed
Last Updated

November 8, 2013

Status Verified

August 1, 2013

Enrollment Period

Same day

First QC Date

November 27, 2012

Results QC Date

August 27, 2013

Last Update Submit

August 27, 2013

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

  • 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

    6 hours

  • 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

    9 hours

  • 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

    12 hours

  • 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

    24 hours

Study Arms (1)

LE Gel

EXPERIMENTAL

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

Interventions

LE GelDRUG

Single drop of LE Gel 0.5% administered to the study eye on visit 2

Also known as: Lotemax
LE Gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb Research Clinic

Rochester, New York, 14609, United States

Location

MeSH Terms

Interventions

Loteprednol Etabonate

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

All 12 subjects were exposed to a single dose of LE Gel.

Results Point of Contact

Title
Raphaële Siou-Mermet, MD, MS
Organization
Bausch & Lomb Incorporated
raphaele.siou-mermet@bausch.com
+33160871491

Study Officials

  • Jeffery Schafer, OD, MS

    Bausch & Lomb Incorporated

    PRINCIPAL INVESTIGATOR

  • Raphaele Siou Mermet, MD, MS

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

November 8, 2013

Results First Posted

November 8, 2013

Record last verified: 2013-08

Locations

US(1)