Clinical trial NCT02547623: Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
Official title: A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: ICON Bioscience Inc
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 194
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.

Detailed description: The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks

Eligibility criteria: Inclusion Criteria:

* undergoing cataract surgery

Exclusion Criteria:

* glaucoma patient, pregnancy, allergy to dexamethasone

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline to postoperative day 90/ early termination
Secondary outcomes:
measure: Intraocular Pressure Measurement
timeFrame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
measure: Visual Acuity in Study Eye
timeFrame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
measure: Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
timeFrame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
measure: Slit Lamp Biomicroscopy - Cornea Edema Grade
timeFrame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
measure: Summary of Concomitant Medications Used in the Study Eye or Both Eyes
timeFrame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
measure: Changes in the Corneal Endothelial Cell Count
timeFrame: Baseline, Postoperative day 90/Early termination
measure: Optic Disc Cup-disc Ratio for the Study Eye
timeFrame: Baseline, POD 90/Early termination
measure: Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
timeFrame: Baseline, POD 90/Early termination
measure: Dilated Opthalmoscopy Findings - Retina (Study Eye)
timeFrame: Baseline, POD 90/Early termination
measure: Dilated Opthalmoscopy Findings - Macula (Study Eye)
timeFrame: Baseline, POD 90/Early termination
measure: Dilated Opthalmoscopy Findings - Choroid (Study Eye)
timeFrame: Baseline, POD 90/Early termination
measure: Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
timeFrame: Baseline, POD 90/Early termination
Other outcomes:
Locations:
city: Glendora
country: United States
facility: Kislinger MD inc
state: California
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associated
state: California
city: Newport Beach
country: United States
facility: Feinerman Vision Center
state: California
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Pennington
country: United States
facility: Matossian Eye Associates
state: New Jersey
city: Garden City
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Mount Pleasant
country: United States
facility: Carolina Eye Care Physicians
state: South Carolina
city: Salt Lake City
country: United States
facility: the eye institute of Utah
state: Utah
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: Eric Donnenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: