Title

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

    Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    ibi-10090 ...
  • Study Participants

    42
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.
Study Started
Oct 31
2010
Primary Completion
May 31
2012
Study Completion
May 31
2012
Results Posted
Sep 18
2013
Estimate
Last Update
Sep 18
2013
Estimate

Drug IBI-10090

Dose 1 Experimental

513ug

Dose 2 Experimental

776ug

Dose 3 Experimental

1046ug

Criteria

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.

Summary

Dose 1

Dose 2

Dose 3

All Events

Event Type Organ System Event Term Dose 1 Dose 2 Dose 3

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.

Dose 1

30.8
percentage of patients with ACC clearing
95% Confidence Interval: 5.68 to 55.86

Dose 2

25.0
percentage of patients with ACC clearing
95% Confidence Interval: 3.78 to 46.22

Dose 3

46.2
percentage of patients with ACC clearing
95% Confidence Interval: 19.05 to 73.25

Total

42
Participants

Age Continuous

72.3
years (Mean)
Standard Deviation: 7.4

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Dose 1

Dose 2

Dose 3

Drop/Withdrawal Reasons

Dose 3