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

Intraocular Pressure Clinical Trial

Official 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%.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521140
• Other study ID #: AVC-002
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Anterior Chamber Inflammation
• Corneal Defect
• Corneal Edema
• Corneal Transplant
• Inflammation
• Intraocular Pressure
• Ocular Pain
• Penetrating KeratoPlasty

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