Conjunctivitis, AllergicPhase 2NCT01289431

Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

A Phase 2 study testing Mapracorat in people with Conjunctivitis, Allergic, 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 objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Conjunctivitis, Allergic
What is being tested?: Mapracorat
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 236 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Apr 2011
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

positive history of ocular allergies and a positive skin test reaction
positive bilateral CAC reaction

Who cannot join

have known contraindications or sensitivities to the use of any of the study medications(s) or their components.
have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters.
had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months;
a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit.
use of any disallowed medications during the period indicated prior to Visit 1 and during the study.
have planned surgery during the trial period or within 30 days after.
have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any type of glaucoma at Visit 1

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb
Rochester, New York, 14609

Other trials in United States

About this study

Official title: Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival Allergen Challenge (CAC).

Conditions: Conjunctivitis, Allergic
Being tested: Mapracorat, Vehicle
Medical subject headings: Conjunctivitis, Allergic

What participants receive

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

MapracoratDrug
administered daily to each eye for 2 weeks following allergen challenge using a CAC model
VehicleDrug
administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Study groups in NCT01289431
Study group	Role	What they receive
Mapracorat	Experimental	Not described Receives: Drug: Mapracorat
Mapracorat Vehicle	Placebo comparator	Not described Receives: Drug: Vehicle

What is being measured

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

Ocular Itching
Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Measured: 8 hours
Conjunctival Redness
Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.
Measured: 8 hours

Secondary outcomes (2)

Ciliary Redness
The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness.
Measured: 8 hours
Episcleral Redness
Episcleral redness was evaluated by the Investigator using a 0-4 scale with half unit increments allowed. A lower score is indicative of less episcleral redness.
Measured: 8 hours

Timeline

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

Feb 2011Apr 2011

First posted3 Feb 2011 (estimated)
Study startFeb 2011
Primary completionApr 2011
Study completionApr 2011

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 Conjunctivitis, AllergicStudies 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: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01289431
Sponsor's protocol ID: 685
Status last verified: Sep 2020
First submitted: 1 Feb 2011
Last updated: 4 Sep 2020
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 Conjunctivitis, Allergic trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival Allergen Challenge (CAC).
ClinicalTrials.gov ID: NCT01289431
Acronym / sponsor ID: 685
Conditions: Conjunctivitis, Allergic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 3 Feb 2011 (estimated)
Results: Posted 4 Sep 2020

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: 2

Arm	Type	Receives
Mapracorat	Experimental	Drug: Mapracorat
Mapracorat Vehicle	Placebo comparator	Drug: Vehicle

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

positive history of ocular allergies and a positive skin test reaction
positive bilateral CAC reaction

Key exclusion criteria (8 listed)

have known contraindications or sensitivities to the use of any of the study medications(s) or their components.
have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters.
had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months;
a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit.

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
Mapracoratadministered daily to each eye for 2 weeks following allergen challenge using a CAC model	Drug	Mapracorat
Vehicleadministered daily to each eye for 2 weeks following allergen challenge using a CAC model	Drug	Mapracorat Vehicle

Primary outcome

Ocular Itching
Time frame: 8 hours
Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Conjunctival Redness
Time frame: 8 hours
Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.

2 secondary outcomes

Ciliary Redness
Time frame: 8 hours
Episcleral Redness
Time frame: 8 hours

Results and safety

Results posted to the registry on 4 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.3% Once a Day	34	29
2% Once a Day	34	32
3% Once a Day	34	30
0.3% Twice a Day	33	28
2% Twice a Day	34	32
3% Twice a Day	33	31
Vehicle	34	33

Primary outcome: Ocular Itching

Time frame: 8 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	0.3% Once a Day n = 30	2% Once a Day n = 33	3% Once a Day n = 30	0.3% Twice a Day n = 28	2% Twice a Day n = 33	3% Twice a Day n = 31	Vehicle n = 33
Value	1.71 (1.212)	1.34 (0.757)	2.11 (1.196)	2.06 (0.880)	1.65 (0.804)	1.58 (0.842)	2.28 (0.985)

Population analysed: Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

Primary outcome: Conjunctival Redness

Time frame: 8 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	0.3% Once a Day n = 30	2% Once a Day n = 33	3% Once a Day n = 30	0.3% Twice a Day n = 28	2% Twice a Day n = 33	3% Twice a Day n = 31	Vehicle n = 33
Value	2.05 (0.757)	1.56 (0.723)	2.01 (0.791)	1.82 (0.779)	1.72 (0.828)	1.81 (0.757)	2.14 (0.631)

Population analysed: Participants with results at the 8 hour timepoint are included, with no imputation for missing data.

2 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
0.3% Once a Day	0 of 34 (0%)	1 of 34 (2.9%)	Not reported
2% Once a Day	0 of 34 (0%)	0 of 34 (0%)	Not reported
3% Once a Day	0 of 34 (0%)	4 of 34 (11.8%)	Not reported
0.3% Twice a Day	0 of 33 (0%)	1 of 33 (3%)	Not reported
2% Twice a Day	0 of 34 (0%)	2 of 34 (5.9%)	Not reported
3% Twice a Day	0 of 33 (0%)	2 of 33 (6.1%)	Not reported
Vehicle	0 of 34 (0%)	7 of 34 (20.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Conjunctivitis, Allergic

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
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RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic

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.

Rabia Ozden, OD 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 2 study testing Mapracorat in people with Conjunctivitis, Allergic, 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 2 inclusion and 8 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 4 Sep 2020. 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 4 Sep 2020). 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: 8 hours). 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 NCT01289431.

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 4 Sep 2020.