Pterygium of Both EyesPhase 4PERSISTNCT04351737
Dextenza for Post-operative Treatment of Pterygium
A Phase 4 study testing Intracanalicular Dexamethasone, (0.4 mg) Insert and Prednisolone Acetate in people with Pterygium of Both Eyes, run by Brandon Eye Associates, PA at 1 site in United States.
Trial summary
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation Compared to Standard of Care Topical Cortico-steroid Treatment in Patients who Undergo Bilateral Pterygium Surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pterygium of Both Eyes
- What is being tested?
- Intracanalicular Dexamethasone, (0.4 mg) Insert and Prednisolone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 23 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation Compared to Standard of Care Topical Cortico-steroid Treatment in Patients who Undergo Bilateral Pterygium Surgery
Read the detailed description
In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.
- Conditions
- Pterygium of Both Eyes
- Being tested
- Intracanalicular Dexamethasone, (0.4 mg) Insert, Prednisolone Acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracanalicular Dexamethasone, (0.4 mg) InsertDrug
Also called Dextenza
To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo bilateral pterygium surgery.
Prednisolone AcetateDrug
To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pterygium patients | Experimental | patients with bilateral pterytium Receives: Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert; Drug: Prednisolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient pain level follow pterygium removal
measurement of pain following pterygium removal using the validated "Numeric Pain Rating Scale" to assess pain, which ranges from 0 to 10 with higher values indicating more severe pain.
Measured: 2 months
inflammation
measurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start15 Jul 2020
- Primary completion15 Jul 2022
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pterygium of Both EyesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brandon Eye Associates, PA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351737
- Sponsor's protocol ID
- PERSIST Study
- Acronym
- PERSIST
- Status last verified
- May 2025
- First submitted
- 11 Mar 2020
- Last updated
- 25 May 2025
- Results posted
- No
- 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study
- ClinicalTrials.gov ID
- NCT04351737
- Acronym / sponsor ID
- PERSIST / PERSIST Study
- Conditions
- Pterygium of Both Eyes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brandon Eye Associates, PAUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 17 Apr 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.
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation Compared to Standard of Care Topical Cortico-steroid Treatment in Patients who Undergo Bilateral Pterygium Surgery
Detailed description
In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.
| Arm | Type | Receives |
|---|---|---|
| Pterygium patients | Experimental | Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert, Drug: Prednisolone Acetatepatients with bilateral pterytium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Intracanalicular Dexamethasone, (0.4 mg) InsertAlso: DextenzaTo determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo bilateral pterygium surgery. | Drug | Pterygium patients |
| Prednisolone AcetateTo reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery. | Drug | Pterygium patients |
Primary outcome
Patient pain level follow pterygium removal
Time frame: 2 months
measurement of pain following pterygium removal using the validated "Numeric Pain Rating Scale" to assess pain, which ranges from 0 to 10 with higher values indicating more severe pain.
inflammation
Time frame: 2 months
measurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation.
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 25 May 2025.
- Individual participant dataSharing planned: No
Related trials for Pterygium of Both Eyes
Not yet recruiting
Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision
Pterygium of Conjunctiva and Cornea, Pterygium of Both Eyes
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intracanalicular Dexamethasone, (0.4 mg) Insert and Prednisolone Acetate in people with Pterygium of Both Eyes, run by Brandon Eye Associates, PA 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 0 inclusion and 1 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 25 May 2025. 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?
Patient pain level follow pterygium removal (time frame: 2 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?
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 25 May 2025.