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Completed

NCT Number: NCT04521140

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.

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Key information

Conditions

Corneal Edema Anterior Chamber Inflammation Corneal Defect Corneal Diseases Corneal Transplant Eye Diseases Eye Manifestations Eye Pain Intraocular Pressure Neurologic Manifestations Ocular Pain Pain Pathological Conditions, Signs and Symptoms Penetrating Keratoplasty Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Advanced Vision Care

Los Angeles, California, 90067, United States

About this study

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower or upper eye lid canaliculus in conjunction with topical prednisolone acetate 1% for the treatment of pain, and inflammation following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

  • Age 18 years and older
  • Scheduled corneal transplant surgery: PKP, DSEK, DMEK
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion criteria

A patient who meets any of the following criteria will be excluded from the study:

  • Patients under the age of 18.
  • Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
  • Active infectious systemic disease
  • Active infectious ocular or extraocular disease
  • Presence of punctal plug in the study eye
  • Obstructed nasolacrimal duct in the study eye(s)
  • Hypersensitivity to dexamethasone or prednisolone eye drops
  • Patients being treated with immunomodulating agents in the study eye(s)
  • Patients being treated with immunosuppressants and/or oral steroids
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Treatment and study plan

Dextenza 0.4Mg Ophthalmic Insert

Drug

DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.

Other names: Dexamethasone Ophthalmic Insert

Prednisolone Acetate 1% Oph Susp

Drug

Prednisolone Acetate 1% is a corticosteroid used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection

Other names: Omnipred, Pred Forte

Primary outcomes

  1. Mean change in pain score

    Time frame: Assessed on Day 1,7 and 30

    as measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible

  2. Mean change in inflammation (Cell and Flare) scores

    Time frame: Assessed on Day 1,7 and 30

    as measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1

Secondary outcomes

  1. Mean change in duration to corneal re-epithelization

    Time frame: Assessed on Day 1 and 7

    as measured by clinical observation of percentage (%); between 0 to 100%; 0 meaning complete re-epithalization and 100% meaning total corneal defect

  2. Mean change in size of epithelial defect

    Time frame: Assessed on Day 1 and 7

    as measured by diameter (mm) of defect; 0 meaning no defect

  3. Impact on the practice/medical team of decreasing the drop burden

    Time frame: Assessed on day 30

    as measured by a questionnaire

  4. Mean change in duration to clearing of corneal edema

    Time frame: Assessed on Day 30, 60 and 90

    as measured by clinical observation; between 0 to 3; 0 meaning clear cornea and 3+ meaning complete obscuration of anterior chamber and iris

Sponsors and collaborators

Lead sponsor

Nicole Fram M.D.

Other

Registry information

Official study title

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Prednisolone Acetate 1% Treating Pain, and inflamMation Following Corneal Transplant Surgery Compared to Topical Prednisolone Acetate 1%.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2020
Registry last updated
Jul 24, 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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