InflammationPhase 3NCT01298752

Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery

A Phase 3 study testing Mapracorat in people with Inflammation and Pain, run by Bausch & Lomb Incorporated at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammation, Pain, Cataract
What is being tested?: Mapracorat
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 177 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Nov 2011
Phase: Phase 3
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who are candidates for routine, uncomplicated cataract surgery.
Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Who cannot join

Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb Incorporated
Rochester, New York, 14609

Other trials in United States

About this study

Official title: The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery

Conditions: Inflammation, Pain, Cataract
Being tested: Mapracorat, Vehicle
Medical subject headings: Inflammation, Pain, Cataract

What participants receive

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

MapracoratDrug
Also called BOL-303242-X
Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
VehicleDrug
Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.

Study groups in NCT01298752
Study group	Role	What they receive
Mapracorat	Experimental	Mapracorat ophthalmic suspension Receives: Drug: Mapracorat
Vehicle	Placebo comparator	Vehicle of mapracorat ophthalmic suspension Receives: Drug: Vehicle

What is being measured

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

Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = >30 cells. Complete resolution of AC cells was defined as Grade 0.
Measured: 8 days
Percentage of Participants With Grade 0 Pain
Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, where higher scores indicated worse pain.
Measured: 8 days

Timeline

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

Feb 2011Nov 2011

First posted18 Feb 2011 (estimated)
Study startFeb 2011
Primary completionSep 2011
Study completionNov 2011

Why it stopped: Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.

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 InflammationStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01298752
Sponsor's protocol ID: 664
Status last verified: Aug 2020
First submitted: 16 Feb 2011
Last updated: 3 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?

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All Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery
ClinicalTrials.gov ID: NCT01298752
Acronym / sponsor ID: 664
Conditions: Inflammation, Pain, Cataract
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Enrolment: 177 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Sep 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 18 Feb 2011 (estimated)
Results: Posted 3 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Mapracorat	Experimental	Drug: MapracoratMapracorat ophthalmic suspension
Vehicle	Placebo comparator	Drug: VehicleVehicle of mapracorat ophthalmic suspension

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects who are candidates for routine, uncomplicated cataract surgery.
Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Key exclusion criteria (3 listed)

Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of 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
MapracoratAlso: BOL-303242-XMapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.	Drug	Mapracorat
VehicleVehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.	Drug	Vehicle

Primary outcome

Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
Time frame: 8 days
Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = >30 cells. Complete resolution of AC cells was defined as Grade 0.
Percentage of Participants With Grade 0 Pain
Time frame: 8 days
Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, where higher scores indicated worse pain.

Results and safety

Results posted to the registry on 3 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
Mapracorat	120	77
Vehicle	57	31

Primary outcome: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.

Time frame: 8 days. Count of participants. Unit: Participants

Measure	Mapracorat n = 114	Vehicle n = 54
Value	9	6

Population analysed: Randomized participants were included without imputation of missing data at 8 days.

Primary outcome: Percentage of Participants With Grade 0 Pain

Time frame: 8 days. Count of participants. Unit: Participants

Measure	Mapracorat n = 114	Vehicle n = 54
Value	65	27

Population analysed: Randomized participants were included without imputation of missing data at 8 days.

Adverse events

Time frame: 18 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mapracorat	0 of 120 (0%)	5 of 120 (4.2%)	Not reported
Vehicle	0 of 57 (0%)	6 of 57 (10.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Rabia Ozden, 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?

A Phase 3 study testing Mapracorat in people with Inflammation and Pain, 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 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: stopped early, as of the sponsor's last update on 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 3 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?

Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. (time frame: 8 days). 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 NCT01298752.

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 3 Sep 2020.