Post Procedural InfectionPhase 4NCT04380857
Assessing Dextenza Insert After SMILE Procedure
A Phase 4 study testing Dexamethasone ophthalmic insert 0.4 mg and Topical Prednisolone Acetate Ophthalmic Drops in people with Post Procedural Infection, run by William Wiley, MD at 1 site in United States.
Trial summary
This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Procedural Infection
- What is being tested?
- Dexamethasone ophthalmic insert 0.4 mg and Topical Prednisolone Acetate Ophthalmic Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2020to 21 Jun 2021
- 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
- Age 18 years and older
- Scheduled for bilateral SMILE surgery
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Who cannot join
- 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
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone
- 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 the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)
This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion
Read the detailed description
4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE.
4.1.1 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 for bilateral SMILE surgery
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
4.1.2 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
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone
- 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
- Conditions
- Post Procedural Infection
- Being tested
- Dexamethasone ophthalmic insert 0.4 mg, Topical Prednisolone Acetate Ophthalmic Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone ophthalmic insert 0.4 mgDrug
Also called Dextenza
intracanalicular dexamethasone insert
Topical Prednisolone Acetate Ophthalmic DropsDrug
Also called Prednisolone Acetate
Topical Prednisolone acetate ophthalmic drops per standard of care:
Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone ophthalmic insert 0.4 mg | Experimental | Dexamethasone ophthalmic insert 0.4 mg Receives: Drug: Dexamethasone ophthalmic insert 0.4 mg |
| Topical prednisolone acetate ophthalmic drops | Active comparator | topical prednisolone acetate ophthalmic drops Receives: Drug: Topical Prednisolone Acetate Ophthalmic Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Pain
post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)
Measured: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90
Secondary outcomes (4)
Number of Lines Lost From Best Corrected Visual Acuity
After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90
Measured: Baseline through Day 90
Loss of Lines in Uncorrected Visual Acuity
All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90.
Measured: Baseline to Day 7, Day 30 and Day 90
Post op Pain Management Per Eye
Count of participants requiring pain management from Day 0 to Day 90.
Measured: Day 0 to Day 90
Patient Preference Between Groups
As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen.
Measured: Day 7, Day 30 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start18 Jun 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
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.
- Other trials for Post Procedural InfectionStudies 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
- First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Wiley, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, William Wiley, MD, Cleveland Eye Clinic
- Investigators
- William Wiley, MD, Principal investigator, Cleveland Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380857
- Sponsor's protocol ID
- WW-2020-DexSMILE
- Status last verified
- Sep 2023
- First submitted
- 5 May 2020
- Last updated
- 6 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)
- ClinicalTrials.gov ID
- NCT04380857
- Acronym / sponsor ID
- WW-2020-DexSMILE
- Conditions
- Post Procedural Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- William Wiley, MDUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion
Detailed description
4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE.
4.1.1 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 for bilateral SMILE surgery
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
4.1.2 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
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone ophthalmic insert 0.4 mg | Experimental | Drug: Dexamethasone ophthalmic insert 0.4 mgDexamethasone ophthalmic insert 0.4 mg |
| Topical prednisolone acetate ophthalmic drops | Active comparator | Drug: Topical Prednisolone Acetate Ophthalmic Dropstopical prednisolone acetate ophthalmic drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and older
- Scheduled for bilateral SMILE surgery
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Key exclusion criteria (8 listed)
- 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
- Obstructed nasolacrimal duct in the study eye(s)
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 |
|---|---|---|
| Dexamethasone ophthalmic insert 0.4 mgAlso: Dextenzaintracanalicular dexamethasone insert | Drug | Dexamethasone ophthalmic insert 0.4 mg |
| Topical Prednisolone Acetate Ophthalmic DropsAlso: Prednisolone AcetateTopical Prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue | Drug | Topical prednisolone acetate ophthalmic drops |
Primary outcome
Mean Change in Pain
Time frame: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90
post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)
4 secondary outcomes
Number of Lines Lost From Best Corrected Visual Acuity
Time frame: Baseline through Day 90
Loss of Lines in Uncorrected Visual Acuity
Time frame: Baseline to Day 7, Day 30 and Day 90
Post op Pain Management Per Eye
Time frame: Day 0 to Day 90
Patient Preference Between Groups
Time frame: Day 7, Day 30 and Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
William Wiley, MD principal investigator
Cleveland Eye Clinic
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 Dexamethasone ophthalmic insert 0.4 mg and Topical Prednisolone Acetate Ophthalmic Drops in people with Post Procedural Infection, run by William Wiley, MD 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 4 inclusion and 8 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 6 Oct 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?
Yes. Results are posted in the registry (first posted 21 Sep 2023). 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?
Mean Change in Pain (time frame: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2023.