Allergic ConjunctivitisPhase 2NCT01107405

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

A Phase 2 study testing Loteprednol etabonate base (QD), Loteprednol etabonate base (BID) and Loteprednol etabonate base (QID) in people with Allergic Conjunctivitis, 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

The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model… Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Loteprednol etabonate base (QD), Loteprednol etabonate base (BID) and Loteprednol etabonate base (QID)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Aug 2010
Phase: Phase 2
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 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.
Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.

Who cannot join

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb
Rochester, New York, 14603

Other trials in United States

About this study

Official title: Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model

Conditions: Allergic Conjunctivitis
Being tested: Loteprednol etabonate base (QD), Loteprednol etabonate base (BID), Loteprednol etabonate base (QID), Loteprednol etabonate suspension, Vehicle of loteprednol etabonate
Medical subject headings: Conjunctivitis, Allergic

What participants receive

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

Loteprednol etabonate base (QD)Drug
Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks
Loteprednol etabonate base (BID)Drug
Loteprednol etabonate ophthalmic base BID dosing for 2 weeks
Loteprednol etabonate base (QID)Drug
Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week
Loteprednol etabonate suspensionDrug
Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.
Vehicle of loteprednol etabonateDrug
Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

Study groups in NCT01107405
Study group	Role	What they receive
Loteprednol etabonate base (QD)	Active comparator	Loteprednol etabonate ophthalmic base dosed once/day. Receives: Drug: Loteprednol etabonate base (QD)
Loteprednol etabonate base (BID)	Active comparator	Loteprednol etabonate ophthalmic base dosed two times/day Receives: Drug: Loteprednol etabonate base (BID)
Loteprednol etabonate base (QID)	Active comparator	Loteprednol etabonate ophthalmic base dosed four times/day. Receives: Drug: Loteprednol etabonate base (QID)
Loteprednol etabonate suspension (QID)	Active comparator	Loteprednol etabonate ophthalmic suspension dosed four times/day Receives: Drug: Loteprednol etabonate suspension
Vehicle of loteprednol etabonate	Placebo comparator	Vehicle of loteprednol etabonate, dosed either QD, BID, or QID Receives: Drug: Vehicle of loteprednol etabonate

What is being measured

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

Ocular Itching
Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Measured: Visit 4 (8 hr re-challenge)
Conjunctival Redness
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
Measured: Visit 4 (8 hr re-challenge)

Secondary outcomes (4)

Ocular Itching
Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Measured: Visit 3 (initial challenge)
Conjunctival Redness
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
Measured: Visit 3 (initial challenge)
Ocular Itching
Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Measured: Visit 4 (initial challenge)
Conjunctival Redness
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
Measured: Visit 4 (initial challenge)

Timeline

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

Apr 2010Aug 2010

First posted21 Apr 2010 (estimated)
Study startApr 2010
Primary completionMay 2010
Study completionAug 2010

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 Allergic ConjunctivitisStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01107405
Sponsor's protocol ID: 584
Status last verified: Feb 2012
First submitted: 15 Apr 2010
Last updated: 21 Mar 2012
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

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model
ClinicalTrials.gov ID: NCT01107405
Acronym / sponsor ID: 584
Conditions: Allergic Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: May 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 21 Apr 2010 (estimated)
Results: Posted 21 Mar 2012

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Loteprednol etabonate base (QD)	Active comparator	Drug: Loteprednol etabonate base (QD)Loteprednol etabonate ophthalmic base dosed once/day.
Loteprednol etabonate base (BID)	Active comparator	Drug: Loteprednol etabonate base (BID)Loteprednol etabonate ophthalmic base dosed two times/day
Loteprednol etabonate base (QID)	Active comparator	Drug: Loteprednol etabonate base (QID)Loteprednol etabonate ophthalmic base dosed four times/day.
Loteprednol etabonate suspension (QID)	Active comparator	Drug: Loteprednol etabonate suspensionLoteprednol etabonate ophthalmic suspension dosed four times/day
Vehicle of loteprednol etabonate	Placebo comparator	Drug: Vehicle of loteprednol etabonateVehicle of loteprednol etabonate, dosed either QD, BID, or QID

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.
Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.

Key exclusion criteria (3 listed)

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to study enrollment or during 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
Loteprednol etabonate base (QD)Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks	Drug	Loteprednol etabonate base (QD)
Loteprednol etabonate base (BID)Loteprednol etabonate ophthalmic base BID dosing for 2 weeks	Drug	Loteprednol etabonate base (BID)
Loteprednol etabonate base (QID)Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week	Drug	Loteprednol etabonate base (QID)
Loteprednol etabonate suspensionLoteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.	Drug	Loteprednol etabonate suspension (QID)
Vehicle of loteprednol etabonateVehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.	Drug	Vehicle of loteprednol etabonate

Primary outcome

Ocular Itching
Time frame: Visit 4 (8 hr re-challenge)
Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Conjunctival Redness
Time frame: Visit 4 (8 hr re-challenge)
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

4 secondary outcomes

Ocular Itching
Time frame: Visit 3 (initial challenge)
Conjunctival Redness
Time frame: Visit 3 (initial challenge)
Ocular Itching
Time frame: Visit 4 (initial challenge)
Conjunctival Redness
Time frame: Visit 4 (initial challenge)

Results and safety

Results posted to the registry on 21 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Loteprednol Etabonate Base (QD)	21	19
Loteprednol Etabonate Base (BID)	20	19
Loteprednol Etabonate Base (QID)	20	18
Loteprednol Etabonate Suspension (QID)	20	17
Vehicle of Loteprednol Etabonate	20	17

Primary outcome: Ocular Itching

Time frame: Visit 4 (8 hr re-challenge). Mean (Standard Deviation). Unit: Units on a Scale

Measure	Loteprednol Etabonate Base (QD) n = 21	Loteprednol Etabonate Base (BID) n = 20	Loteprednol Etabonate Base (QID) n = 18	Loteprednol Etabonate Suspension (QID) n = 19	Vehicle of Loteprednol Etabonate n = 19
3 Min	1.48 (1.040)	1.84 (0.978)	1.82 (0.954)	1.93 (0.794)	2.68 (0.916)
5 Min	1.63 (1.036)	2.13 (0.988)	1.96 (0.960)	2.12 (0.918)	2.78 (0.924)
7 Min	1.54 (1.035)	2.03 (1.097)	1.89 (0.993)	2.04 (0.951)	2.71 (0.899)

Population analysed: Visit 4, Re-challenge Ocular Itching Scores - Primary Analysis ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.

Primary outcome: Conjunctival Redness

Time frame: Visit 4 (8 hr re-challenge). Mean (Standard Deviation). Unit: Units on a scale

Measure	Loteprednol Etabonate Base (QD) n = 21	Loteprednol Etabonate Base (BID) n = 20	Loteprednol Etabonate Base (QID) n = 18	Loteprednol Etabonate Suspension (QID) n = 19	Vehicle of Loteprednol Etabonate n = 19
7 min	1.76 (0.620)	1.99 (0.709)	2.11 (0.649)	2.16 (0.619)	2.59 (0.501)
15 min	1.95 (0.660)	2.13 (0.829)	2.28 (0.766)	2.18 (0.600)	2.71 (0.597)
20 min	2.02 (0.720)	2.06 (0.811)	2.28 (0.691)	2.16 (0.585)	2.74 (0.592)

Population analysed: Visit 4, Re-challenge Conjunctival Hyperemia Scores, ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loteprednol Etabonate Base (QD)	0 of 21 (0%)	0 of 21 (0%)	Not reported
Loteprednol Etabonate Base (BID)	0 of 20 (0%)	4 of 20 (20%)	Not reported
Loteprednol Etabonate Base (QID)	0 of 20 (0%)	5 of 20 (25%)	Not reported
Loteprednol Etabonate Suspension (QID)	0 of 20 (0%)	1 of 20 (5%)	Not reported
Vehicle of Loteprednol Etabonate	0 of 20 (0%)	6 of 20 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Conjunctivitis

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
RecruitingObservational study
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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.

Tuyen Ong, MD 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?

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 4 inclusion and 3 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 21 Mar 2012. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Mar 2012). 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?

Ocular Itching (time frame: Visit 4 (8 hr re-challenge)). The study lists 2 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 NCT01107405.

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 21 Mar 2012.