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

Cataract Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316936
• Other study ID #: 1
• Status: Completed
• Phase: Phase 4
• Start date: December 10, 2019
• Est. completion date: December 23, 2020

Study information

• Verified date: June 2023
• Source: Silverstein Eye Centers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 23, 2020
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Drug:
• Omidria
phenylephrine 1% and ketorolac 0.3% intraocular solution
• Dextenza (dexamethasone ophthalmic insert) 0.4mg
intracanalicular dexamethasone insert
• Dexycu, 9% Intraocular Suspension
dexamethasone intraocular suspension
• Prednisolone Acetate 1%
standard postoperative ophthalmic drop regimen

Locations

Country	Name	City	State
United States	Silverstein Eye Centers	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Silverstein Eye Centers	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optical Coherence Tomography (OCT)	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. .	Assessed pre-operatively and 1 month post-operatively
Other	Contrast sensitivity testing	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.	Assessed pre-operatively, and at 15 days and 30 days post-operatively
Other	Best corrected visual acuity	ETDRS chart at 4m	Assessed pre-operatively, and at 15 days and 30 days post-operatively
Other	Optical Coherence Tomography (OCT)	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.	Assessed pre-operatively and 1 month post-operatively
Primary	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
Primary	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
Primary	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	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).	Assessed at day 1 post-operatively
Secondary	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).	Assessed at day 8 post-operatively