PharmacokineticsPhase 1NCT01736527

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

A Phase 1 study testing LE Gel in people with Pharmacokinetics, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: LE Gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Apr 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb Research Clinic
Rochester, New York, 14609

Other trials in United States

About this study

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

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.

Conditions: Pharmacokinetics
Being tested: LE Gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LE GelDrug
Also called Lotemax
Single drop of LE Gel 0.5% administered to the study eye on visit 2

Study groups in NCT01736527
Study group	Role	What they receive
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. Receives: Drug: LE Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Apr 2013

First posted29 Nov 2012 (estimated)
Study startJan 2013
Primary completionJan 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01736527
Sponsor's protocol ID: 808
Status last verified: Aug 2013
First submitted: 27 Nov 2012
Last updated: 8 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01736527
Acronym / sponsor ID: 808
Conditions: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Jan 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 29 Nov 2012 (estimated)
Results: Posted 8 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LE Gel	Experimental	Drug: LE GelA 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LE GelAlso: LotemaxSingle drop of LE Gel 0.5% administered to the study eye on visit 2	Drug	LE Gel

Primary outcome

Tear Fluid Levels
Time frame: 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
Tear Fluid Levels
Time frame: 9 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
Tear Fluid Levels
Time frame: 12 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
Tear Fluid Levels
Time frame: 24 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

Results and safety

Results posted to the registry on 8 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LE Gel	12	12

Primary outcome: Tear Fluid Levels

Time frame: 6 hours. Mean (Standard Deviation). Unit: μg/g

Measure	LE Gel n = 12
Value	113.633 (116.0133)

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

Primary outcome: Tear Fluid Levels

Time frame: 9 hours. Mean (Standard Deviation). Unit: μg/g

Measure	LE Gel n = 10
Value	19.667 (18.1625)

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

Primary outcome: Tear Fluid Levels

Time frame: 12 hours. Mean (Standard Deviation). Unit: μg/g

Measure	LE Gel n = 12
Value	26.877 (29.6464)

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

Primary outcome: Tear Fluid Levels

Time frame: 24 hours. Mean (Standard Deviation). Unit: μg/g

Measure	LE Gel n = 11
Value	2.408 (3.3631)

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

Adverse events

Time frame: 24 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LE Gel	0 of 12 (0%)	1 of 12 (8.3%)	Not reported

Limitations and caveats (from the sponsor): All 12 subjects were exposed to a single dose of LE Gel.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Pyelonephritis
Not yet recruitingPhase 1
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Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
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Study of PTC844 in Participants With Active Rheumatoid Arthritis
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RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffery Schafer, OD, MS principal investigator

Bausch & Lomb Incorporated

Raphaele Siou Mermet, MD, MS study director

Bausch & Lomb Incorporated

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LE Gel in people with Pharmacokinetics, run by Bausch & Lomb Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear Fluid Levels (time frame: 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.