Back to resultsOmidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
Primary Purpose
Cataract Surgery
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omidria
Dextenza (dexamethasone ophthalmic insert) 0.4mg
Dexycu, 9% Intraocular Suspension
Prednisolone Acetate 1%
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Surgery focused on measuring Dextenza, intracanalicular dexamethasone, dexamethasone ophthalmic insert, Dexycu, Omidria
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.
Sites / Locations
- Silverstein Eye Centers
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg
Omidria + Dexycu
Omidria + Prednisolone Acetate 1%
Arm Description
Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)
Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension
Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops
Outcomes
Primary Outcome Measures
Resolution of anterior chamber inflammation
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Resolution of anterior chamber inflammation
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Resolution of anterior chamber inflammation
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Secondary Outcome Measures
Resolution of postoperative pain
The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).
Resolution of postoperative pain
The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).
Full Information
NCT ID
NCT04316936
First Posted
March 17, 2020
Last Updated
June 13, 2023
Sponsor
Silverstein Eye Centers
Collaborators
Ocular Therapeutix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04316936
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 23, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Silverstein Eye Centers
Collaborators
Ocular Therapeutix, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
Keywords
Dextenza, intracanalicular dexamethasone, dexamethasone ophthalmic insert, Dexycu, Omidria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg
Arm Type
Experimental
Arm Description
Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)
Arm Title
Omidria + Dexycu
Arm Type
Experimental
Arm Description
Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension
Arm Title
Omidria + Prednisolone Acetate 1%
Arm Type
Active Comparator
Arm Description
Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops
Intervention Type
Drug
Intervention Name(s)
Omidria
Intervention Description
phenylephrine 1% and ketorolac 0.3% intraocular solution
Intervention Type
Drug
Intervention Name(s)
Dextenza (dexamethasone ophthalmic insert) 0.4mg
Intervention Description
intracanalicular dexamethasone insert
Intervention Type
Drug
Intervention Name(s)
Dexycu, 9% Intraocular Suspension
Intervention Description
dexamethasone intraocular suspension
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate 1%
Intervention Description
standard postoperative ophthalmic drop regimen
Primary Outcome Measure Information:
Title
Resolution of anterior chamber inflammation
Description
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Time Frame
Assessed at day 8 post-operatively
Title
Resolution of anterior chamber inflammation
Description
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Time Frame
Assessed at day 15 post-operatively
Title
Resolution of anterior chamber inflammation
Description
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Time Frame
Assessed at day 30 post-operatively
Secondary Outcome Measure Information:
Title
Resolution of postoperative pain
Description
The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).
Time Frame
Assessed at day 1 post-operatively
Title
Resolution of postoperative pain
Description
The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).
Time Frame
Assessed at day 8 post-operatively
Other Pre-specified Outcome Measures:
Title
Optical Coherence Tomography (OCT)
Description
OCT is a non-contact, non-invasive test that takes less than a minute to perform. All that is required of the patient is that they sit still and look at a fixation light while the machine takes a picture. No eye drops or any other intervention are required. OCT scanning will provide an image of the deep layers of the retina and will be used to determine macular thickness measurement (macular thickness has been correlated to changes in contrast sensitivity) before and 30 days following surgery. .
Time Frame
Assessed pre-operatively and 1 month post-operatively
Title
Contrast sensitivity testing
Description
This test is non-contact, non-invasive and used to distinguish between finer and finer increments of light versus dark. The patient simply looks at a chart similar to the Snellen Eye Chart and distinguishes lighter shades from darker shades. The test is performed in less than one minute.
Time Frame
Assessed pre-operatively, and at 15 days and 30 days post-operatively
Title
Best corrected visual acuity
Description
ETDRS chart at 4m
Time Frame
Assessed pre-operatively, and at 15 days and 30 days post-operatively
Title
Optical Coherence Tomography (OCT)
Description
OCT is a non-contact, non-invasive test that takes less than a minute to perform. All that is required of the patient is that they sit still and look at a fixation light while the machine takes a picture. No eye drops or any other intervention are required. OCT scanning will provide an image of the deep layers of the retina and will be used to evaluate for the presence of cystoid macular edema before and 30 days following surgery.
Time Frame
Assessed pre-operatively and 1 month post-operatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
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