Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery
Study Details
Study Description
Brief 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%.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed 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%.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: PKP with Dextenza (study) Patients undergoing PKP will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks |
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.
Other Names:
Drug: 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
Other Names:
|
Other: PKP without Dextenza (Controlled) Patients undergoing PKP will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks |
Drug: 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
Other Names:
|
Experimental: DSEK with Dextenza (study) Patients undergoing DSEK will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks |
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.
Other Names:
Drug: 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
Other Names:
|
Other: DSEK without Dextenza (Controlled) Patients undergoing DSEK will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks |
Drug: 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
Other Names:
|
Experimental: DMEK with Dextenza (study) will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks |
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.
Other Names:
Drug: 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
Other Names:
|
Other: DMEK without Dextenza (Controlled) Patients undergoing DMEK will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks |
Drug: 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean change in pain score [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
- Mean change in inflammation (Cell and Flare) scores [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 Outcome Measures
- Mean change in duration to corneal re-epithelization [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
- Mean change in size of epithelial defect [Assessed on Day 1 and 7]
as measured by diameter (mm) of defect; 0 meaning no defect
- Impact on the practice/medical team of decreasing the drop burden [Assessed on day 30]
as measured by a questionnaire
- Mean change in duration to clearing of corneal edema [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
Eligibility Criteria
Criteria
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
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Scheduled corneal transplant surgery: PKP, DSEK, DMEK
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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:
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Patients under the age of 18.
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Advanced Vision Care | Los Angeles | California | United States | 90067 |
Sponsors and Collaborators
- Nicole Fram M.D.
Investigators
- Principal Investigator: Nicole Fram, MD, Advanced Vision Care
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- AVC-002