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

NCT01298752 | Terminated Phase 3 Results

• 1 other identifier: 664
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Pain; Cataract

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 days

Study Arms (2)

Mapracorat

EXPERIMENTAL

Mapracorat ophthalmic suspension

Drug: Mapracorat

Vehicle

PLACEBO COMPARATOR

Vehicle of mapracorat ophthalmic suspension

Drug: Vehicle

Interventions

Mapracorat DRUG

Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.

Also known as: BOL-303242-X

Mapracorat

Vehicle DRUG

Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Inflammation; Pain; Cataract

Interventions

R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

Study Officials

• Rabia Ozden, MD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 3, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-08

Locations

US (1)