Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

NCT02547623 | Completed Phase 3 Results

• 1 other identifier: C15-01
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 11

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to postoperative day 90/ early termination

Secondary Outcomes (12)

• 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

Study Arms (2)

dexamethasone depot

ACTIVE COMPARATOR

dexamethasone depot 517 mcg

Drug: Dexamethasone

standard of care

ACTIVE COMPARATOR

prednisolone drops 1%

Drug: Prednisolone

Interventions

Dexamethasone DRUG

depot intracameral

Also known as: Dexycu

dexamethasone depot

Prednisolone DRUG

Prednisolone eye drops 1%

Also known as: standard of care

standard of care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing cataract surgery

You may not qualify if:

• glaucoma patient, pregnancy, allergy to dexamethasone

Sponsors & Collaborators

• ICON Bioscience Inc: lead

Study Sites (11)

Kislinger MD inc

Glendora, California, 91741, United States

Location

Inland Eye Specialists

Hemet, California, 92545, United States

Location

Harvard Eye Associated

Laguna Hills, California, 92653, United States

Location

Feinerman Vision Center

Newport Beach, California, 92663, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Associated Eye Care

Stillwater, Minnesota, 55082, United States

Location

Matossian Eye Associates

Pennington, New Jersey, 08534, United States

Location

Ophthalmic Consultants of Long Island

Garden City, New York, 11530, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Carolina Eye Care Physicians

Mt. Pleasant, South Carolina, 29464, United States

Location

the eye institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Dexamethasone; Calcium Dobesilate; Prednisolone; Standard of Care

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Vice President, Quality and Compliance
• Organization: Icon Bioscience, Inc.

510-933-8381

Study Officials

• Eric Donnenfeld, MD

  Ophthalmic Consultants of Long Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: November 6, 2015
• Primary Completion: August 16, 2016
• Study Completion: August 16, 2016
• Last Updated: August 21, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-07

Locations

US (11)