The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
Condition: Inflammation; Cataracts
MeSH terms: Cataract; Inflammation
Intervention: IBI-10090; Placebo
Intervention description: Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 394.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Inflammation; cataract surgery

Summary:

      The purpose of this study is to determine whether IBI-10090 injection is effective in the
      treatment of inflammation associated with cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient must provide written informed consent by signing the Informed Consent
             approved by the Institutional Review Board (IRB).

          2. Male or female patients at least 40 years of age scheduled for unilateral cataract
             surgery by phacoemulsification with posterior chamber intraocular lens implantation.

          3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with
             glare testing, if necessary) in the study eye and better than 20/200 in the fellow
             eye.

          4. The patient must be considered by the Investigator to have visual acuity potential
             greater than 20/30 in the study eye.

          5. The patient must have a corneal endothelial cell count by specular microscopy in the
             study eye of at least 2000 cells/mm2 with normal cell morphology.

          6. A female patient of childbearing potential (premenopausal by medical history) must
             have a negative pregnancy test on Day 0 and be using an effective method of birth
             control (although no birth control method is 100% effective, the following are
             considered effective means of contraception: surgical sterilization, use of oral
             contraceptives, barrier contraception using either a condom or diaphragm with
             spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch)
             from Screening for the duration of the study.

          7. The patient must be willing and able to understand and comply with the study
             procedures and to communicate meaningfully with study personnel.

        Key Exclusion Criteria:

          1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior
             to Day 0.

          2. Patients who have received a periocular corticosteroid injection in the study eye in
             the 3 months prior to screening.

          3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g.,
             Retisert, Ozurdex, Iluvien) in the study eye at any time.

          4. Patients who anticipate requiring treatment with any corticosteroids by any route,
             except inhalation, during the study.

          5. Patients with an allergy or hypersensitivity to dexamethasone.

          6. Patients who are known steroid responders (corticosteroid-related intraocular pressure
             elevation in either eye).

          7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to
             Day 0.

          8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye
             within 6 months prior to screening.

          9. Patients who have undergone prior intraocular laser surgery in the study eye within 3
             months prior to screening.

         10. Patients with planned intraocular or laser surgery in the study eye for the duration
             of the study.