Trial Outcomes & Findings for Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation (NCT NCT01736527)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

6 hours

Results posted on

2013-11-08

Participant Flow

Single center, open label, single dose study in healthy volunteers. First participant enrolled 01/08/2013, last participant exited: 01/18/2013.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LE Gel n=12 Participants 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
Age, Customized	45.6 years STANDARD_DEVIATION 11.37 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.

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

Outcome measures

Outcome measures
Measure	LE Gel n=12 Participants 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
Tear Fluid Levels	113.633 μg/g Standard Deviation 116.0133

PRIMARY outcome

Timeframe: 9 hours

Population: The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.

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

Outcome measures

Outcome measures
Measure	LE Gel n=10 Participants 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
Tear Fluid Levels	19.667 μg/g Standard Deviation 18.1625

PRIMARY outcome

Timeframe: 12 hours

Population: The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.

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

Outcome measures

Outcome measures
Measure	LE Gel n=12 Participants 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
Tear Fluid Levels	26.877 μg/g Standard Deviation 29.6464

PRIMARY outcome

Timeframe: 24 hours

Population: The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.

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

Outcome measures

Outcome measures
Measure	LE Gel n=11 Participants 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
Tear Fluid Levels	2.408 μg/g Standard Deviation 3.3631

Adverse Events

LE Gel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LE Gel n=12 participants at risk 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
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • 24 hours All 12 subjects were exposed to a single dose of LE Gel.

Additional Information

Raphaële Siou-Mermet, MD, MS

Bausch & Lomb Incorporated

Phone: +33160871491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place