Dextenza in Pterygium Surgery

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)

Study Overview

• Status: Completed
• Conditions: Pterygium
• Intervention / Treatment: Drug: Dexamethasone Intracanalicular Insert, 0.4mg; Drug: Prednisolone Acetate 1%

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York Eye Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEXTENZA Group; Patients with Pterygium DEXTENZA Group	Drug: Dexamethasone Intracanalicular Insert, 0.4mg; To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.
Experimental: Topical Prednisolone Acetate 1% Group; Patients with Pterygium Topical Prednisolone Acetate 1% Group	Drug: Prednisolone Acetate 1%; To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Post-Op Day 1
Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Week 1
Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Month 1
Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Month 3
Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Week 1
To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Month 1
To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Month 2
To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Month 3
To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Month 6
Mean number of days for corneal re-epithelialization	As evaluated by slit lamp examination	Assessed on Post-Op Day 1
Mean number of days for corneal re-epithelialization	As evaluated by slit lamp examination	Assessed on Week 1
Mean number of days for corneal re-epithelialization	As evaluated by slit lamp examination	Assessed on Month 1
Recurrence of pterygium	As measured by yes or no on recurrence; external eye examination	Assessed at Month 1
Recurrence of pterygium	As measured by yes or no on recurrence; external eye examination	Assessed at Month 2
Recurrence of pterygium	As measured by yes or no on recurrence; external eye examination	Assessed at Month 3
Recurrence of pterygium	As measured by yes or no on recurrence; external eye examination	Assessed at Month 6

Collaborators and Investigators

• Sponsor: Michelle Rhee MD
• Collaborators: Ocular Therapeutix, Inc.
• Investigators: Principal Investigator: Michelle K Rhee, MD, New York Eye Specialists

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): August 5, 2021
• Study Completion (Actual): August 5, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: Dextenza in Pterygium Surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes