NCT01606735

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 22, 2014

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

May 24, 2012

Results QC Date

September 2, 2014

Last Update Submit

September 17, 2014

Conditions

Inflammation Associated With Cataract Surgery

Keywords

cataract surgeryocular inflammation

Outcome Measures

Primary Outcomes (1)

  • Anterior Chamber Cell Count at Day 8 Post-Treatment

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

    8 days post-treatment

Study Arms (3)

Dose 1

EXPERIMENTAL
Drug: IBI-10090

Dose 2

EXPERIMENTAL
Drug: IBI-10090

Dose 3

EXPERIMENTAL
Drug: IBI-10090

Interventions

IBI-10090DRUG

dexamethasone

Dose 1Dose 2Dose 3

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for unilateral cataract surgery

You may not qualify if:

  • Ocular, topical, or oral corticosteroids within 7 days of Day 0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inland Eye Specialists

Hemet, California, 92545, United States

Location

California Eye Professionals

Temecula, California, 92591, United States

Location

Results Point of Contact

Title
Wendy Murahashi, MD
Organization
Icon Bioscience, Inc
wendymurahashi@iconbioscience.com
6503694049

Study Officials

  • Wendy Murahashi, MD

    Sponsor GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 22, 2014

Results First Posted

September 22, 2014

Record last verified: 2014-09

Locations

US(2)