Dextenza in Pterygium Surgery

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2020

Detailed Description

In patients who undergo pterygium surgery, eyes will be randomized 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.

Interventions

  • 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.
  • Drug: Prednisolone Acetate 1%
    • To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.

Arms, Groups and Cohorts

  • Experimental: DEXTENZA Group
    • Patients with Pterygium DEXTENZA Group
  • Experimental: Topical Prednisolone Acetate 1% Group
    • Patients with Pterygium Topical Prednisolone Acetate 1% Group

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Michelle Rhee MD
  • Collaborator
    • Ocular Therapeutix, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Michelle Rhee MD, Principal Investigator – New York Eye Specialists
  • Overall Official(s)
    • Michelle K Rhee, MD, Principal Investigator, New York Eye Specialists
  • Overall Contact(s)
    • Michelle K Rhee, MD, 646-543-2015, drmichellerhee@gmail.com

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