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

Sponsor
Nicole Fram M.D. (Other)
Overall Status
Recruiting
CT.gov ID
NCT04521140
Collaborator
(none)
30
Enrollment
1
Location
6
Arms
19.5
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Drug: Dextenza 0.4Mg Ophthalmic Insert
  • Drug: Prednisolone Acetate 1% Oph Susp
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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
In patient who undergo corneal transplant (PKP,DSEK,DMEK), subjects will be randomized to 6 arms and be followed for a period of 3 months. First arm will Receive Dextenza with PKP, Second arm will receive Prednisolone Acetate 1% with PKP, Third arm will Receive Dextenza with DSEK, Forth arm will receive Prednisolone Acetate 1% with DSEK Fifth arm will Receive Dextenza with DMEK, Sixth arm will receive Prednisolone Acetate 1% with DMEKIn patient who undergo corneal transplant (PKP,DSEK,DMEK), subjects will be randomized to 6 arms and be followed for a period of 3 months. First arm will Receive Dextenza with PKP, Second arm will receive Prednisolone Acetate 1% with PKP, Third arm will Receive Dextenza with DSEK, Forth arm will receive Prednisolone Acetate 1% with DSEK Fifth arm will Receive Dextenza with DMEK, Sixth arm will receive Prednisolone Acetate 1% with DMEK
Masking:
None (Open Label)
Primary Purpose:
Treatment
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%.
Actual Study Start Date :
Oct 16, 2020
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

ArmIntervention/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:
  • Dexamethasone Ophthalmic Insert
  • 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:
  • Omnipred, Pred Forte
  • 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:
  • Omnipred, Pred Forte
  • 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:
  • Dexamethasone Ophthalmic Insert
  • 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:
  • Omnipred, Pred Forte
  • 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:
  • Omnipred, Pred Forte
  • 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:
  • Dexamethasone Ophthalmic Insert
  • 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:
  • Omnipred, Pred Forte
  • 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:
  • Omnipred, Pred Forte
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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

    2. Mean change in size of epithelial defect [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 [Assessed on day 30]

      as measured by a questionnaire

    4. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Advanced Vision CareLos AngelesCaliforniaUnited States90067

    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

    Responsible Party:
    Nicole Fram M.D., Principal Investigator, Advanced Vision Care
    ClinicalTrials.gov Identifier:
    NCT04521140
    Other Study ID Numbers:
    • AVC-002
    First Posted:
    Aug 20, 2020
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 24, 2020