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

Ocular Inflammation Clinical Trial

Official title:

A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Treating Inflammation in Cataract Surgery Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01214174
• Other study ID #: C10-01
• Status: Terminated
• Phase: Phase 2
• First received: September 21, 2010
• Last updated: September 16, 2013
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: September 2013
• Source: ICON Bioscience Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Ocular Inflammation

Intervention

Drug:
• IBI-10090

Locations

Country	Name	City	State
United States	Drs. Fine, Hoffman, and Packer	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
ICON Bioscience Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No