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

NCT04316936 | Completed Phase 4 FDA Drug

• 1 other identifier: 1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Surgery

Keywords

Dextenza; intracanalicular dexamethasone; dexamethasone ophthalmic insert; Dexycu; Omidria

Outcome Measures

Primary Outcomes (3)

• 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.

  Assessed at day 8 post-operatively

• 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.

  Assessed at day 15 post-operatively

• 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.

  Assessed at day 30 post-operatively

Secondary Outcomes (2)

• Resolution of postoperative pain

  Assessed at day 1 post-operatively

• Resolution of postoperative pain

  Assessed at day 8 post-operatively

Other Outcomes (4)

• Optical Coherence Tomography (OCT)

  Assessed pre-operatively and 1 month post-operatively

• Contrast sensitivity testing

  Assessed pre-operatively, and at 15 days and 30 days post-operatively

• Best corrected visual acuity

  Assessed pre-operatively, and at 15 days and 30 days post-operatively

Study Arms (3)

Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg

EXPERIMENTAL

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

Drug: Omidria; Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg

Omidria + Dexycu

EXPERIMENTAL

Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension

Drug: Omidria; Drug: Dexycu, 9% Intraocular Suspension

Omidria + Prednisolone Acetate 1%

ACTIVE COMPARATOR

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

Drug: Omidria; Drug: Prednisolone Acetate 1%

Interventions

Omidria DRUG

phenylephrine 1% and ketorolac 0.3% intraocular solution

Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg; Omidria + Dexycu; Omidria + Prednisolone Acetate 1%

Dextenza (dexamethasone ophthalmic insert) 0.4mg DRUG

intracanalicular dexamethasone insert

Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg

Dexycu, 9% Intraocular Suspension DRUG

dexamethasone intraocular suspension

Omidria + Dexycu

Prednisolone Acetate 1% DRUG

standard postoperative ophthalmic drop regimen

Omidria + Prednisolone Acetate 1%

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silverstein Eye Centers: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

MeSH Terms

Interventions

Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 20, 2020
• Study Start: December 10, 2019
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (1)