NCT01591161

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

Completed Phase 3 Results posted Last updated 18 August 2020

What this trial tests

Phase 3 trial testing Mapracorat in Cataract in 369 participants. Completed in 1 July 2013.

Timeline

1 July 2012

Primary endpoint
1 June 2013

1 July 2013

Quick facts

Lead sponsor	Bausch & Lomb Incorporated
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	369
Start date	1 July 2012
Primary completion	1 June 2013
Estimated completion	1 July 2013
Sites	1 location across United States

Drugs / interventions tested

• Mapracorat — full drug profile →
• Placebo

Conditions studied

• Cataract — all drugs for Cataract →
• Inflammation — all drugs for Inflammation →
• Surgery — all drugs for Surgery →

Sponsor

Bausch & Lomb Incorporated — full company profile →

Who can join

18 and older, any sex, with Cataract or Inflammation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 c
• 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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improved Glucocorticoid Receptor Ligands: Fantastic Beasts, but How to Find Them?
   Van Moortel L, Gevaert K, De Bosscher K. · · 2020 · cited 29× · PMID 33071974 · DOI 10.3389/fendo.2020.559673