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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04521140
Other study ID # AVC-002
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 16, 2020
Est. completion date January 4, 2023

Study information

Verified date July 2023
Source Advanced Vision Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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%.


Description:

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%.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 4, 2023
Est. primary completion date January 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Dextenza 0.4Mg Ophthalmic Insert
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.
Prednisolone Acetate 1% Oph Susp
Prednisolone Acetate 1% is a corticosteroid used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection

Locations

Country Name City State
United States Advanced Vision Care Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Nicole Fram M.D.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Anshu A, Price MO, Price FW Jr. Risk of corneal transplant rejection significantly reduced with Descemet's membrane endothelial keratoplasty. Ophthalmology. 2012 Mar;119(3):536-40. doi: 10.1016/j.ophtha.2011.09.019. Epub 2012 Jan 3. — View Citation

Price MO, Scanameo A, Feng MT, Price FW Jr. Descemet's Membrane Endothelial Keratoplasty: Risk of Immunologic Rejection Episodes after Discontinuing Topical Corticosteroids. Ophthalmology. 2016 Jun;123(6):1232-6. doi: 10.1016/j.ophtha.2016.02.001. Epub 2016 Mar 13. — View Citation

Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24. Erratum In: J Cataract Refract Surg. 2019 Jun;45(6):895. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in pain score as measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible Assessed on Day 1,7 and 30
Primary Mean change in inflammation (Cell and Flare) scores 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 Assessed on Day 1,7 and 30
Secondary Mean change in duration to corneal re-epithelization as measured by clinical observation of percentage (%); between 0 to 100%; 0 meaning complete re-epithalization and 100% meaning total corneal defect Assessed on Day 1 and 7
Secondary Mean change in size of epithelial defect as measured by diameter (mm) of defect; 0 meaning no defect Assessed on Day 1 and 7
Secondary Impact on the practice/medical team of decreasing the drop burden as measured by a questionnaire Assessed on day 30
Secondary Mean change in duration to clearing of corneal edema as measured by clinical observation; between 0 to 3; 0 meaning clear cornea and 3+ meaning complete obscuration of anterior chamber and iris Assessed on Day 30, 60 and 90
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