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Dextenza in Pterygium Surgery

Primary Purpose

Pterygium

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Intracanalicular Insert, 0.4mg
Prednisolone Acetate 1%
Sponsored by
Michelle Rhee MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Eye Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DEXTENZA Group

Topical Prednisolone Acetate 1% Group

Arm Description

Patients with Pterygium DEXTENZA Group

Patients with Pterygium Topical Prednisolone Acetate 1% Group

Outcomes

Primary Outcome Measures

Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire
Patient satisfaction-comfort and convenience
Assessed by patient reported questionnaire

Secondary Outcome Measures

To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
To compare the degree of conjunctival hyperemia
Assessed by clinical external photography
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Mean number of days for corneal re-epithelialization
As evaluated by slit lamp examination
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination
Recurrence of pterygium
As measured by yes or no on recurrence; external eye examination

Full Information

First Posted
May 12, 2020
Last Updated
April 4, 2022
Sponsor
Michelle Rhee MD
Collaborators
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04403516
Brief Title
Dextenza in Pterygium Surgery
Official Title
Dextenza in Pterygium Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
August 5, 2021 (Actual)
Study Completion Date
August 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle Rhee MD
Collaborators
Ocular Therapeutix, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEXTENZA Group
Arm Type
Experimental
Arm Description
Patients with Pterygium DEXTENZA Group
Arm Title
Topical Prednisolone Acetate 1% Group
Arm Type
Experimental
Arm Description
Patients with Pterygium Topical Prednisolone Acetate 1% Group
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Intracanalicular Insert, 0.4mg
Intervention Description
To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate 1%
Intervention Description
To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.
Primary Outcome Measure Information:
Title
Patient satisfaction-comfort and convenience
Description
Assessed by patient reported questionnaire
Time Frame
Assessed on Post-Op Day 1
Title
Patient satisfaction-comfort and convenience
Description
Assessed by patient reported questionnaire
Time Frame
Assessed on Week 1
Title
Patient satisfaction-comfort and convenience
Description
Assessed by patient reported questionnaire
Time Frame
Assessed on Month 1
Title
Patient satisfaction-comfort and convenience
Description
Assessed by patient reported questionnaire
Time Frame
Assessed on Month 3
Title
Patient satisfaction-comfort and convenience
Description
Assessed by patient reported questionnaire
Time Frame
Assessed on Month 6
Secondary Outcome Measure Information:
Title
To compare the degree of conjunctival hyperemia
Description
Assessed by clinical external photography
Time Frame
Assessed on Week 1
Title
To compare the degree of conjunctival hyperemia
Description
Assessed by clinical external photography
Time Frame
Assessed on Month 1
Title
To compare the degree of conjunctival hyperemia
Description
Assessed by clinical external photography
Time Frame
Assessed on Month 2
Title
To compare the degree of conjunctival hyperemia
Description
Assessed by clinical external photography
Time Frame
Assessed on Month 3
Title
To compare the degree of conjunctival hyperemia
Description
Assessed by clinical external photography
Time Frame
Assessed on Month 6
Title
Mean number of days for corneal re-epithelialization
Description
As evaluated by slit lamp examination
Time Frame
Assessed on Post-Op Day 1
Title
Mean number of days for corneal re-epithelialization
Description
As evaluated by slit lamp examination
Time Frame
Assessed on Week 1
Title
Mean number of days for corneal re-epithelialization
Description
As evaluated by slit lamp examination
Time Frame
Assessed on Month 1
Title
Recurrence of pterygium
Description
As measured by yes or no on recurrence; external eye examination
Time Frame
Assessed at Month 1
Title
Recurrence of pterygium
Description
As measured by yes or no on recurrence; external eye examination
Time Frame
Assessed at Month 2
Title
Recurrence of pterygium
Description
As measured by yes or no on recurrence; external eye examination
Time Frame
Assessed at Month 3
Title
Recurrence of pterygium
Description
As measured by yes or no on recurrence; external eye examination
Time Frame
Assessed at Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle K Rhee, MD
Organizational Affiliation
New York Eye Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Eye Specialists
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Dextenza in Pterygium Surgery

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