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%.
Overview
- Phase
- Phase 4
- Intervention
- Dextenza 0.4Mg Ophthalmic Insert
- Conditions
- Corneal Edema
- Sponsor
- Nicole Fram M.D.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Mean change in pain score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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%.
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%.
Investigators
Nicole Fram M.D.
Principal Investigator
Advanced Vision Care
Eligibility 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
- •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
Arms & Interventions
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
Intervention: Dextenza 0.4Mg Ophthalmic Insert
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
Intervention: Prednisolone Acetate 1% Oph Susp
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
Intervention: Prednisolone Acetate 1% Oph Susp
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
Intervention: Dextenza 0.4Mg Ophthalmic Insert
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
Intervention: Prednisolone Acetate 1% Oph Susp
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
Intervention: Prednisolone Acetate 1% Oph Susp
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
Intervention: Dextenza 0.4Mg Ophthalmic Insert
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
Intervention: Prednisolone Acetate 1% Oph Susp
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
Intervention: Prednisolone Acetate 1% Oph Susp
Outcomes
Primary Outcomes
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
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 Outcomes
- Mean change in duration to corneal re-epithelization(Assessed on Day 1 and 7)
- Mean change in size of epithelial defect(Assessed on Day 1 and 7)
- Impact on the practice/medical team of decreasing the drop burden(Assessed on day 30)
- Mean change in duration to clearing of corneal edema(Assessed on Day 30, 60 and 90)