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

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ClinicalTrials.gov Identifier: NCT04521140
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nicole Fram M.D., Advanced Vision Care

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
Corneal Edema Corneal Defect Corneal Transplant Penetrating KeratoPlasty Anterior Chamber Inflammation Ocular Pain 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%.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : October 16, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022


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 Name: 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 Name: Omnipred, Pred Forte

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 Name: 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 Name: 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 Name: Omnipred, Pred Forte

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 Name: 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 Name: 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 Name: Omnipred, Pred Forte

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 Name: Omnipred, Pred Forte




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521140


Contacts
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Contact: Nicole R Fram, M.D. 310-229-1220 nicfram@yahoo.com
Contact: Orly Shiler 310-229-1220 orlyjr@inorbit.com

Locations
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United States, California
Advanced Vision Care Recruiting
Los Angeles, California, United States, 90067
Contact: Orly Shiler    310-229-1220    orlyjr@inorbit.com   
Sponsors and Collaborators
Nicole Fram M.D.
Investigators
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Principal Investigator: Nicole Fram, MD Advanced Vision Care
Publications:
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Responsible Party: Nicole Fram M.D., Principal Investigator, Advanced Vision Care
ClinicalTrials.gov Identifier: NCT04521140    
Other Study ID Numbers: AVC-002
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Corneal Edema
Inflammation
Pathologic Processes
Corneal Diseases
Eye Diseases
Dexamethasone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents