NCT04351737

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

March 11, 2020

Last Update Submit

May 21, 2025

Conditions

Pterygium of Both Eyes

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 months

Study Arms (1)

Pterygium patients

EXPERIMENTAL

patients with bilateral pterytium

Drug: Intracanalicular Dexamethasone, (0.4 mg) InsertDrug: Prednisolone Acetate

Interventions

Intracanalicular Dexamethasone, (0.4 mg) InsertDRUG

To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo bilateral pterygium surgery.

Also known as: Dextenza
Pterygium patients
Prednisolone AcetateDRUG

To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.

Pterygium patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brandon Eye Associates

Brandon, Florida, 33511, United States

Location

MeSH Terms

Interventions

Mutagenesis, InsertionalCalcium Dobesilateprednisolone acetate

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesisBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

April 17, 2020

Study Start

July 15, 2020

Primary Completion

July 15, 2022

Study Completion

May 23, 2023

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)