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

Cataract Clinical Trial

Official title:

Study to Assess the Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230125
• Other study ID #: 663
• Status: Completed
• Phase: Phase 3
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants who are candidates for routine, uncomplicated cataract surgery

• Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.

• Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

• Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.

• Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.

• Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).

• Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.

• Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• Mapracorat
Instill study medication into study eye per dosing instructions for 14 days
• Vehicle
Instill study medication into the study eye per dosing instructions for 14 days

Locations

Country	Name	City	State
United States	Bausch & Lomb, Incorporated	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	8 days
Secondary	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.	8 days