PterygiumPhase 4NCT04403516
Dextenza in Pterygium Surgery
A Phase 4 study testing Dexamethasone Intracanalicular Insert, 0.4mg and Prednisolone Acetate 1% in people with Pterygium, run by Michelle Rhee MD at 1 site in United States.
Trial summary
DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- Dexamethasone Intracanalicular Insert, 0.4mg and Prednisolone Acetate 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 5 Aug 2021
- 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
Who may be able to join
- A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- Age of at least 18 years with primary pterygia
Who cannot join
- A patient who meets any of the following criteria will be excluded from the study:
- Glaucoma
- Ocular hypertension
- Prior conjunctival surgery
- Other uncontrolled ocular disease
- Ocular surgery in either eye within 3 months
- Use of eye drops other than postoperative medications and artificial tears
Trial locations and contacts
1 site in 1 country.
About this study
DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft)
Read the detailed description
In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.
- Conditions
- Pterygium
- Being tested
- Dexamethasone Intracanalicular Insert, 0.4mg, Prednisolone Acetate 1%
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Intracanalicular Insert, 0.4mgDrug
To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.
Prednisolone Acetate 1%Drug
To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.
| Study group | Role | What they receive |
|---|---|---|
| DEXTENZA Group | Experimental | Patients with Pterygium DEXTENZA Group Receives: Drug: Dexamethasone Intracanalicular Insert, 0.4mg |
| Topical Prednisolone Acetate 1% Group | Experimental | Patients with Pterygium Topical Prednisolone Acetate 1% Group Receives: Drug: Prednisolone Acetate 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Measured: Assessed on Post-Op Day 1
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Measured: Assessed on Week 1
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Measured: Assessed on Month 1
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Measured: Assessed on Month 3
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Measured: Assessed on Month 6
Secondary outcomes (12)
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Measured: Assessed on Week 1
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Measured: Assessed on Month 1
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Measured: Assessed on Month 2
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Measured: Assessed on Month 3
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Measured: Assessed on Month 6
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Measured: Assessed on Post-Op Day 1
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Measured: Assessed on Week 1
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Measured: Assessed on Month 1
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Measured: Assessed at Month 1
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Measured: Assessed at Month 2
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Measured: Assessed at Month 3
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Measured: Assessed at Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Oct 2020
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PterygiumStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA (15 eyes) into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued or receive topical prednisolone acetate 1% (15 eyes) q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Rhee MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor-investigator, Michelle Rhee MD, New York Eye Specialists
- Investigators
- Michelle K Rhee, MD, Principal investigator, New York Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403516
- Sponsor's protocol ID
- Dextenza in Pterygium Surgery
- Status last verified
- Apr 2022
- First submitted
- 12 May 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rhee MK, Zakher M, Najac M, Arias H, Jo J, Gorham R, Moadel K. Comparing Intracanalicular and Topical Steroid Use in Patients Undergoing Pterygium Surgery. Eye Contact Lens. 2024 Apr 1;50(4):183-188. doi: 10.1097/ICL.0000000000001075. Epub 2024 Feb 1.
PubMed 38305478
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextenza in Pterygium Surgery
- ClinicalTrials.gov ID
- NCT04403516
- Acronym / sponsor ID
- Dextenza in Pterygium Surgery
- Conditions
- Pterygium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Michelle Rhee MDUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 27 May 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 prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft)
Detailed description
In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA (15 eyes) into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued or receive topical prednisolone acetate 1% (15 eyes) q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.
| Arm | Type | Receives |
|---|---|---|
| DEXTENZA Group | Experimental | Drug: Dexamethasone Intracanalicular Insert, 0.4mgPatients with Pterygium DEXTENZA Group |
| Topical Prednisolone Acetate 1% Group | Experimental | Drug: Prednisolone Acetate 1%Patients with Pterygium Topical Prednisolone Acetate 1% Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- Age of at least 18 years with primary pterygia
Key exclusion criteria (7 listed)
- Glaucoma
- Ocular hypertension
- Prior conjunctival surgery
- Other uncontrolled ocular disease
- Ocular surgery in either eye within 3 months
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 Intracanalicular Insert, 0.4mgTo determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery. | Drug | DEXTENZA Group |
| Prednisolone Acetate 1%To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery. | Drug | Topical Prednisolone Acetate 1% Group |
Primary outcome
Patient satisfaction-comfort and convenience
Time frame: Assessed on Post-Op Day 1
Assessed by patient reported questionnaire
Patient satisfaction-comfort and convenience
Time frame: Assessed on Week 1
Assessed by patient reported questionnaire
Patient satisfaction-comfort and convenience
Time frame: Assessed on Month 1
Assessed by patient reported questionnaire
Patient satisfaction-comfort and convenience
Time frame: Assessed on Month 3
Assessed by patient reported questionnaire
Patient satisfaction-comfort and convenience
Time frame: Assessed on Month 6
Assessed by patient reported questionnaire
12 secondary outcomes
To compare the degree of conjunctival hyperemia
Time frame: Assessed on Week 1
To compare the degree of conjunctival hyperemia
Time frame: Assessed on Month 1
To compare the degree of conjunctival hyperemia
Time frame: Assessed on Month 2
To compare the degree of conjunctival hyperemia
Time frame: Assessed on Month 3
To compare the degree of conjunctival hyperemia
Time frame: Assessed on Month 6
Mean number of days for corneal re-epithelialization
Time frame: Assessed on Post-Op Day 1
Mean number of days for corneal re-epithelialization
Time frame: Assessed on Week 1
Mean number of days for corneal re-epithelialization
Time frame: Assessed on Month 1
Recurrence of pterygium
Time frame: Assessed at Month 1
Recurrence of pterygium
Time frame: Assessed at Month 2
Recurrence of pterygium
Time frame: Assessed at Month 3
Recurrence of pterygium
Time frame: Assessed at Month 6
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 6 Apr 2022.
- Derived from this study: PubMed 38305478Rhee MK, Zakher M, Najac M, Arias H, Jo J, Gorham R, Moadel K. Comparing Intracanalicular and Topical Steroid Use in Patients Undergoing Pterygium Surgery. Eye Contact Lens. 2024 Apr 1;50(4):183-188. doi: 10.1097/ICL.0000000000001075. Epub 2024 Feb 1.
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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.
Michelle K Rhee, MD principal investigator
New York Eye Specialists
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 Intracanalicular Insert, 0.4mg and Prednisolone Acetate 1% in people with Pterygium, run by Michelle Rhee 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 2 inclusion and 7 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 Apr 2022. 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 satisfaction-comfort and convenience (time frame: Assessed on Post-Op Day 1). The study lists 5 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 NCT04403516, which also lists 1 linked publication.
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 Apr 2022.