Corneal Endothelial DystrophyPhase 4NCT05136443
Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
A Phase 4 study testing loteprednol etabonate 0.25% ophthalmic suspension in people with Corneal Endothelial Dystrophy and Corneal Edema, run by Price Vision Group at 1 site in United States.
Trial summary
The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Endothelial Dystrophy, Corneal Edema
- What is being tested?
- loteprednol etabonate 0.25% ophthalmic suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2021to 5 Sep 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- o At least 18 years of age
- Male or female patient who had DMEK within the past 1 to 7 weeks.
- Patient is able and willing to administer eye drops.
- Patient is able to comprehend and has signed the Informed Consent form.
- Patient is likely to complete the 11-month study duration.
Who cannot join
- o A history of a previous rejection episode in the study eye
- A patient exhibiting intraocular inflammation.
- A patient with a known sensitivity to any of the ingredients in the study medications
- A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
- A patient with abnormal eyelid function.
- A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.
Show all 9Show fewer
- Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.
- A patient with a history of non-compliance with using prescribed medication.
- Patients who are pregnant or planning to become pregnant within the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty
The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.
- Conditions
- Corneal Endothelial Dystrophy, Corneal Edema
- Being tested
- loteprednol etabonate 0.25% ophthalmic suspension
- Medical subject headings
- Corneal Dystrophy, Posterior Polymorphous, 1, Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loteprednol etabonate 0.25% ophthalmic suspensionDrug
Also called Eysuvis
tapering dose
| Study group | Role | What they receive |
|---|---|---|
| Preventative Treatment | Experimental | Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam. Receives: Drug: loteprednol etabonate 0.25% ophthalmic suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic Rejection
incidence of immunologic rejection episodes
Measured: 11 months
Steroid-induced Ocular Hypertension
incidence of steroid-induced ocular hypertension
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start23 Nov 2021
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Corneal Endothelial DystrophyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Price Vision Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kala Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Francis W Price, Jr., MD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136443
- Sponsor's protocol ID
- 2021-002
- Status last verified
- Sep 2023
- First submitted
- 29 Oct 2021
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Price MO, Feng MT, Scanameo A, Price FW Jr. Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial. Cornea. 2015 Aug;34(8):853-8. doi: 10.1097/ICO.0000000000000475.
PubMed 26020827Price MO, Price FW Jr, Kruse FE, Bachmann BO, Tourtas T. Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane endothelial keratoplasty. Cornea. 2014 Sep;33(9):880-6. doi: 10.1097/ICO.0000000000000206.
PubMed 25062336Price MO, Feng MT, Gang A, Price FW Jr. Prospective Assessment of Loteprednol Etabonate 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty in Eyes With Fuchs Dystrophy. Cornea. 2024 Aug 1;43(8):1028-1030. doi: 10.1097/ICO.0000000000003398. Epub 2023 Sep 21.
PubMed 37733966
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty
- ClinicalTrials.gov ID
- NCT05136443
- Acronym / sponsor ID
- 2021-002
- Conditions
- Corneal Endothelial Dystrophy, Corneal Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Price Vision GroupIndustry (pharma, biotech, devices)
- Collaborators
- Kala Pharmaceuticals, Inc.
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 29 Nov 2021 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preventative Treatment | Experimental | Drug: loteprednol etabonate 0.25% ophthalmic suspensionLoteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- o At least 18 years of age
Key exclusion criteria (9 listed)
- o A history of a previous rejection episode in the study eye
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 |
|---|---|---|
| loteprednol etabonate 0.25% ophthalmic suspensionAlso: Eysuvistapering dose | Drug | Preventative Treatment |
Primary outcome
Immunologic Rejection
Time frame: 11 months
incidence of immunologic rejection episodes
Steroid-induced Ocular Hypertension
Time frame: 11 months
incidence of steroid-induced ocular hypertension
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26020827Price MO, Feng MT, Scanameo A, Price FW Jr. Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial. Cornea. 2015 Aug;34(8):853-8. doi: 10.1097/ICO.0000000000000475.
- Background: PubMed 25062336Price MO, Price FW Jr, Kruse FE, Bachmann BO, Tourtas T. Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane endothelial keratoplasty. Cornea. 2014 Sep;33(9):880-6. doi: 10.1097/ICO.0000000000000206.
- Results publication: PubMed 37733966Price MO, Feng MT, Gang A, Price FW Jr. Prospective Assessment of Loteprednol Etabonate 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty in Eyes With Fuchs Dystrophy. Cornea. 2024 Aug 1;43(8):1028-1030. doi: 10.1097/ICO.0000000000003398. Epub 2023 Sep 21.
- Individual participant dataSharing planned: No
Related trials for Corneal Endothelial Dystrophy
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Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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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.
Francis W Price, Jr., MD principal investigator
Price Vision Group
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 loteprednol etabonate 0.25% ophthalmic suspension in people with Corneal Endothelial Dystrophy and Corneal Edema, run by Price Vision Group 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?
The sponsor lists 5 inclusion and 9 exclusion criteria. 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 14 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Immunologic Rejection (time frame: 11 months). 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 NCT05136443, 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 14 Aug 2024.