The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 352
Inclusion Criteria
- The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.
- The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
- 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.
- ...
- The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.
- The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
- 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.
- The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
- 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.
- Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
- 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.
Exclusion Criteria
- Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
- Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
- Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
- ...
- Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
- Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
- Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
- Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
- Patients with an allergy or hypersensitivity to dexamethasone.
- Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
- Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
- Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
- Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
Summary
- Conditions
- Cataracts
- Inflammation
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
Description
A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)
A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)
Inclusion Criteria
- The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.
- The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
- 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.
- ...
- The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.
- The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
- 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.
- The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
- 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.
- Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
- 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.
Exclusion Criteria
- Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
- Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
- Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
- ...
- Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
- Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
- Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
- Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
- Patients with an allergy or hypersensitivity to dexamethasone.
- Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
- Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
- Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
- Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
Tracking Information
- NCT #
- NCT02006888
- Collaborators
- Not Provided
- Investigators
- Study Director: howard franklin, md ICON Bioscience Inc