Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery

Sponsor
Silverstein Eye Centers (Other)
Overall Status
Recruiting
CT.gov ID
NCT04316936
Collaborator
Ocular Therapeutix, Inc. (Industry)
75
Enrollment
1
Location
3
Arms
12.7
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Omidria
  • Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg
  • Drug: Dexycu, 9% Intraocular Suspension
  • Drug: Prednisolone Acetate 1%
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 10, 2019
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg

Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)

Drug: Omidria
phenylephrine 1% and ketorolac 0.3% intraocular solution

Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg
intracanalicular dexamethasone insert

Experimental: Omidria + Dexycu

Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension

Drug: Omidria
phenylephrine 1% and ketorolac 0.3% intraocular solution

Drug: Dexycu, 9% Intraocular Suspension
dexamethasone intraocular suspension

Active Comparator: Omidria + Prednisolone Acetate 1%

Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops

Drug: Omidria
phenylephrine 1% and ketorolac 0.3% intraocular solution

Drug: Prednisolone Acetate 1%
standard postoperative ophthalmic drop regimen

Outcome Measures

Primary Outcome Measures

  1. Resolution of anterior chamber inflammation [Assessed at day 8 post-operatively]

    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.

  2. Resolution of anterior chamber inflammation [Assessed at day 15 post-operatively]

    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.

  3. Resolution of anterior chamber inflammation [Assessed at day 30 post-operatively]

    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

  1. Resolution of postoperative pain [Assessed at day 1 post-operatively]

    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).

  2. Resolution of postoperative pain [Assessed at day 8 post-operatively]

    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).

Other Outcome Measures

  1. Optical Coherence Tomography (OCT) [Assessed pre-operatively and 1 month post-operatively]

    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. .

  2. Contrast sensitivity testing [Assessed pre-operatively, and at 15 days and 30 days post-operatively]

    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.

  3. Best corrected visual acuity [Assessed pre-operatively, and at 15 days and 30 days post-operatively]

    ETDRS chart at 4m

  4. Optical Coherence Tomography (OCT) [Assessed pre-operatively and 1 month post-operatively]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Silverstein Eye CentersKansas CityMissouriUnited States64133

Sponsors and Collaborators

  • Silverstein Eye Centers
  • Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Silverstein Eye Centers
ClinicalTrials.gov Identifier:
NCT04316936
Other Study ID Numbers:
  • 1
First Posted:
Mar 20, 2020
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020
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
Keywords provided by Silverstein Eye Centers
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2020