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Completed

NCT Number: NCT04316936

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

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.

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Key information

Conditions

Cataract Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omidria

Drug

phenylephrine 1% and ketorolac 0.3% intraocular solution

Dextenza (dexamethasone ophthalmic insert) 0.4mg

Drug

intracanalicular dexamethasone insert

Dexycu, 9% Intraocular Suspension

Drug

dexamethasone intraocular suspension

Prednisolone acetate 1%

Drug

standard postoperative ophthalmic drop regimen

Primary outcomes

  1. Resolution of anterior chamber inflammation

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Resolution of postoperative pain

    Time frame: 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

    Time frame: 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 outcomes

  1. Optical Coherence Tomography (OCT)

    Time frame: 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

    Time frame: 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

    Time frame: Assessed pre-operatively, and at 15 days and 30 days post-operatively

    ETDRS chart at 4m

  4. Optical Coherence Tomography (OCT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Silverstein Eye Centers

Other

Collaborators

  • Ocular Therapeutix, Inc.

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2020
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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