CataractPhase 3NCT01591161
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
A Phase 3 study testing Mapracorat in people with Cataract and Inflammation, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its 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
- Cataract, Inflammation, Surgery
- What is being tested?
- Mapracorat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2013
- 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 who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
- Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).
Who cannot join
- 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.
- Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
- Presence of active external ocular disease: infection or inflammation of the study eye.
- Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
- Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Rochester, New York, 14609
About this study
Official title: The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
- Conditions
- Cataract, Inflammation, Surgery
- Being tested
- Mapracorat, Placebo
- Medical subject headings
- Cataract, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapracoratDrug
1 drop of study medication into the study eye QID for 14 days
PlaceboDrug
1 drop of vehicle into the study eye QID for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Mapracorat | Experimental | Mapracorat ophthalmic suspension, 3%, Receives: Drug: Mapracorat |
| Vehicle | Placebo comparator | The vehicle of the mapracorat ophthalmic suspension Receives: Drug: Placebo |
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
Secondary outcomes (6)
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: 15 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, were higher scores indicated worse pain.
Measured: 15 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution was defined as Grade 0.
Measured: 15 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.
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.
Anterior Chamber Flare: A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution was defined as Grade 0.
Measured: 15 days
Change From Baseline Anterior Chamber (AC) Cells and Flare Combined
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.
Anterior Chamber Flare: A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect.
The combined score could be at minimum 0 and at most 8, with higher scores indicating worse outcome.
Measured: 15 days
Percentage of Treatment Failures
Treatment failure was defined as anterior chamber (AC) cell score worsened or remained the same, and the Investigator deemed it necessary to place the participant on rescue therapy.
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. Pigment cells and red blood cells are to be ignored. 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJul 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 CataractStudies 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
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Quintus Ngumah, OD, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591161
- Sponsor's protocol ID
- 790
- Status last verified
- Aug 2020
- First submitted
- 2 May 2012
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 and Pain Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT01591161
- Acronym / sponsor ID
- 790
- Conditions
- Cataract, Inflammation, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 3 May 2012 (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.
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
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, 3%, |
| Vehicle | Placebo comparator | Drug: PlaceboThe vehicle of the 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 (3 listed)
- Subjects who are candidates for routine, uncomplicated cataract surgery.
- Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
- Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).
Key exclusion criteria (5 listed)
- 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.
- Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
- Presence of active external ocular disease: infection or inflammation of the study eye.
- Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
- Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
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 |
|---|---|---|
| Mapracorat1 drop of study medication into the study eye QID for 14 days | Drug | Mapracorat |
| Placebo1 drop of vehicle into the study eye QID for 14 days. | 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.
6 secondary outcomes
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
Time frame: 15 days
Percentage of Participants With Grade 0 Pain
Time frame: 15 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
Time frame: 15 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.
Time frame: 15 days
Change From Baseline Anterior Chamber (AC) Cells and Flare Combined
Time frame: 15 days
Percentage of Treatment Failures
Time frame: 8 days
Results and safety
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.
Quintus Ngumah, OD, PhD 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 Cataract and Inflammation, 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 3 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 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?
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.