Clinical trial NCT04316936: Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
Official title: Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract Surgery
Keywords: Dextenza
intracanalicular dexamethasone
dexamethasone ophthalmic insert
Dexycu
Omidria
Lead sponsor: Silverstein Eye Centers
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-03-20
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to 1 of 3 groups (1:1:1), each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria.
Primary purpose: TREATMENT

Brief summary: This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.

Detailed description: Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.

Exclusion Criteria:

* Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.

Primary outcomes:
measure: Resolution of anterior chamber inflammation
timeFrame: Assessed at day 8 post-operatively
measure: Resolution of anterior chamber inflammation
timeFrame: Assessed at day 15 post-operatively
measure: Resolution of anterior chamber inflammation
timeFrame: Assessed at day 30 post-operatively
Secondary outcomes:
measure: Resolution of postoperative pain
timeFrame: Assessed at day 1 post-operatively
measure: Resolution of postoperative pain
timeFrame: Assessed at day 8 post-operatively
Other outcomes:
measure: Optical Coherence Tomography (OCT)
timeFrame: Assessed pre-operatively and 1 month post-operatively
measure: Contrast sensitivity testing
timeFrame: Assessed pre-operatively, and at 15 days and 30 days post-operatively
measure: Best corrected visual acuity
timeFrame: Assessed pre-operatively, and at 15 days and 30 days post-operatively
measure: Optical Coherence Tomography (OCT)
timeFrame: Assessed pre-operatively and 1 month post-operatively
Locations:
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
Study officials:
References: