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Completed

NCT Number: NCT01230125

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

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.

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Key information

Conditions

Cataract Eye Diseases Inflammation Lens Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bausch & Lomb, Incorporated

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mapracorat

Drug

Instill study medication into study eye per dosing instructions for 14 days

Other names: BOL-303242-X

Vehicle

Drug

Instill study medication into the study eye per dosing instructions for 14 days

Primary outcomes

  1. 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.

  2. 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, were higher scores indicated worse pain.

Secondary outcomes

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

    Time frame: 8 days

    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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2010
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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