Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients

NCT01214174 | Terminated Phase 2 Results

• 1 other identifier: C10-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.

Conditions

Ocular Inflammation

Keywords

cataract; inflammation

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment

  This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.

  8 days post-treatment

Study Arms (3)

Dose 1

EXPERIMENTAL

513ug

Drug: IBI-10090

Dose 2

EXPERIMENTAL

776ug

Drug: IBI-10090

Dose 3

EXPERIMENTAL

1046ug

Drug: IBI-10090

Interventions

IBI-10090 DRUG

Dose 1; Dose 2; Dose 3

Eligibility Criteria

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

You may qualify if:

• Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.

You may not qualify if:

• Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0.
• Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
• Patients with any signs of intraocular inflammation in either eye at screening.
• Patients who have received any prior intravitreal injections in the study eye.

Sponsors & Collaborators

• ICON Bioscience Inc: lead

Study Sites (1)

Drs. Fine, Hoffman, and Packer

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Cataract; Inflammation

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Wendy Murahashi, MD
• Organization: Icon Bioscience, Inc.

wendymurahashi@iconbioscience.com

650-369-4049

Study Officials

• Mark Packer, MD

  Drs. Fine, Hoffman, Packer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: October 4, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 18, 2013
• Results First Posted: September 18, 2013

Record last verified: 2013-09

Locations

US (1)