Inflammatory Reaction Due to Ocular Lens Prosthesis Clinical Trial
Official title:
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Cataract Surgery Patients
| NCT number | NCT01048593 |
| Other study ID # | C09-01 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | January 2010 |
| Est. completion date | June 2010 |
| Verified date | November 2018 |
| Source | ICON Bioscience Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | June 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Altos Eye Physicians | Los Altos | California |
| Lead Sponsor | Collaborator |
|---|---|
| ICON Bioscience Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clearance of Anterior Chamber Cells | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8. | Day 8 post treatment | |
| Secondary | Anterior Chamber Flare (ACF) Grade | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4. | Day 90 post-treatment | |
| Secondary | Conjunctival Erythema Grade | Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. | Day 90 post-treatment | |
| Secondary | Corneal Edema Grade | Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. | Day 90 post-treatment | |
| Secondary | Anterior Chamber Cell Grade | Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4. | Day 90 post-treatment |