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Clinical Trials/NCT02547623
NCT02547623CompletedPhase 3

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

ICON Bioscience Inc10 sites in 1 country194 target enrollmentStarted: November 6, 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
194
Locations
10
Primary Endpoint
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •undergoing cataract surgery

Exclusion Criteria

  • •glaucoma patient, pregnancy, allergy to dexamethasone

Arms & Interventions

dexamethasone depot

Active Comparator

dexamethasone depot 517 mcg

Intervention: Dexamethasone (Drug)

standard of care

Active Comparator

prednisolone drops 1%

Intervention: Prednisolone (Drug)

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time Frame: Baseline to postoperative day 90/ early termination

Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.

Secondary Outcomes

  • Intraocular Pressure Measurement(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
  • Visual Acuity in Study Eye(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
  • Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
  • Slit Lamp Biomicroscopy - Cornea Edema Grade(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
  • Summary of Concomitant Medications Used in the Study Eye or Both Eyes(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
  • Changes in the Corneal Endothelial Cell Count(Baseline, Postoperative day 90/Early termination)
  • Optic Disc Cup-disc Ratio for the Study Eye(Baseline, POD 90/Early termination)
  • Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)(Baseline, POD 90/Early termination)
  • Dilated Opthalmoscopy Findings - Retina (Study Eye)(Baseline, POD 90/Early termination)
  • Dilated Opthalmoscopy Findings - Macula (Study Eye)(Baseline, POD 90/Early termination)
  • Dilated Opthalmoscopy Findings - Choroid (Study Eye)(Baseline, POD 90/Early termination)
  • Dilated Opthalmoscopy Findings - Vitreous (Study Eye)(Baseline, POD 90/Early termination)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (10)

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