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

NCT01591161 | Completed Phase 3 Results

• 1 other identifier: 790
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract; Inflammation; Surgery

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

Secondary Outcomes (6)

• Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.

  15 days

• Percentage of Participants With Grade 0 Pain

  15 days

• Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.

  15 days

• Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.

  15 days

• Change From Baseline Anterior Chamber (AC) Cells and Flare Combined

  15 days

Study Arms (2)

Mapracorat

EXPERIMENTAL

Mapracorat ophthalmic suspension, 3%,

Drug: Mapracorat

Vehicle

PLACEBO COMPARATOR

The vehicle of the mapracorat ophthalmic suspension

Drug: Placebo

Interventions

Mapracorat DRUG

1 drop of study medication into the study eye QID for 14 days

Mapracorat

Placebo DRUG

1 drop of vehicle into the study eye QID for 14 days.

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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Cataract; Inflammation

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)

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

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

Study Officials

• Quintus Ngumah, OD, PhD

  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: May 2, 2012
• First Posted: May 3, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 3, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-08

Locations

US (1)