Corneal EdemaPhase 4NCT04521140
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp in people with Corneal Edema and Corneal Defect, run by Nicole Fram M.D. at 1 site in United States.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Edema, Corneal Defect, Corneal Transplant
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 4 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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%.
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%.
Read the 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%.
- Conditions
- Corneal Edema, Corneal Defect, Corneal Transplant, Penetrating KeratoPlasty, Anterior Chamber Inflammation, Ocular Pain
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp
- Medical subject headings
- Corneal Edema, Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4Mg Ophthalmic InsertDrug
Also called Dexamethasone 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 SuspDrug
Also called Omnipred, Pred Forte
Prednisolone Acetate 1% is a corticosteroid used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection
| Study group | Role | What they receive |
|---|---|---|
| PKP with Dextenza (study) | Experimental | 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 Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp |
| PKP without Dextenza (Controlled) | Other | 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 Receives: Drug: Prednisolone Acetate 1% Oph Susp |
| DSEK with Dextenza (study) | Experimental | 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 Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp |
| DSEK without Dextenza (Controlled) | Other | 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 Receives: Drug: Prednisolone Acetate 1% Oph Susp |
| DMEK with Dextenza (study) | Experimental | 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 Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp |
| DMEK without Dextenza (Controlled) | Other | 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 Receives: Drug: Prednisolone Acetate 1% Oph Susp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed on Day 1,7 and 30
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
Measured: Assessed on Day 1,7 and 30
Secondary outcomes (4)
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
Measured: Assessed on Day 1 and 7
Mean change in size of epithelial defect
as measured by diameter (mm) of defect; 0 meaning no defect
Measured: Assessed on Day 1 and 7
Impact on the practice/medical team of decreasing the drop burden
as measured by a questionnaire
Measured: Assessed on day 30
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
Measured: Assessed on Day 30, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start16 Oct 2020
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicole Fram M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicole Fram M.D., Advanced Vision Care
- Investigators
- Nicole Fram, MD, Principal investigator, Advanced Vision Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521140
- Sponsor's protocol ID
- AVC-002
- Status last verified
- Jul 2023
- First submitted
- 18 Aug 2020
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22218143Price 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.
PubMed 26983976Tyson 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.
PubMed 30367938
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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%.
- ClinicalTrials.gov ID
- NCT04521140
- Acronym / sponsor ID
- AVC-002
- Conditions
- Corneal Edema, Corneal Defect, Corneal Transplant, Penetrating KeratoPlasty, Anterior Chamber Inflammation, Ocular Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nicole Fram M.D.University, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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
| Arm | Type | Receives |
|---|---|---|
| PKP with Dextenza (study) | Experimental | Drug: Dextenza 0.4Mg Ophthalmic Insert, Drug: Prednisolone Acetate 1% Oph SuspPatients 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 |
| PKP without Dextenza (Controlled) | Other | Drug: Prednisolone Acetate 1% Oph SuspPatients 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 |
| DSEK with Dextenza (study) | Experimental | Drug: Dextenza 0.4Mg Ophthalmic Insert, Drug: Prednisolone Acetate 1% Oph SuspPatients 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 |
| DSEK without Dextenza (Controlled) | Other | Drug: Prednisolone Acetate 1% Oph SuspPatients 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 |
| DMEK with Dextenza (study) | Experimental | Drug: Dextenza 0.4Mg Ophthalmic Insert, Drug: Prednisolone Acetate 1% Oph Suspwill 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 |
| DMEK without Dextenza (Controlled) | Other | Drug: Prednisolone Acetate 1% Oph SuspPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextenza 0.4Mg Ophthalmic InsertAlso: Dexamethasone Ophthalmic InsertDEXTENZA 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. | Drug | DMEK with Dextenza (study), DSEK with Dextenza (study), PKP with Dextenza (study) |
| Prednisolone Acetate 1% Oph SuspAlso: Omnipred, Pred FortePrednisolone Acetate 1% is a corticosteroid used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection | Drug | DMEK with Dextenza (study), DMEK without Dextenza (Controlled), DSEK with Dextenza (study), DSEK without Dextenza (Controlled), PKP with Dextenza (study), PKP without Dextenza (Controlled) |
Primary outcome
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
4 secondary outcomes
Mean change in duration to corneal re-epithelization
Time frame: Assessed on Day 1 and 7
Mean change in size of epithelial defect
Time frame: Assessed on Day 1 and 7
Impact on the practice/medical team of decreasing the drop burden
Time frame: Assessed on day 30
Mean change in duration to clearing of corneal edema
Time frame: Assessed on Day 30, 60 and 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 22218143Anshu 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.
- Background: PubMed 26983976Price 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.
- Background: PubMed 30367938Tyson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Fram, MD principal investigator
Advanced Vision Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp in people with Corneal Edema and Corneal Defect, run by Nicole Fram M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in pain score (time frame: Assessed on Day 1,7 and 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04521140, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.