Dextenza in Pterygium Surgery

NCT04403516 | Completed Phase 4 FDA Drug

• 1 other identifier: Dextenza in Pterygium Surgery
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Pterygium

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• To compare the degree of conjunctival hyperemia

  Assessed on Week 1

• To compare the degree of conjunctival hyperemia

  Assessed on Month 1

• To compare the degree of conjunctival hyperemia

  Assessed on Month 2

• To compare the degree of conjunctival hyperemia

  Assessed on Month 3

• To compare the degree of conjunctival hyperemia

  Assessed on Month 6

Study Arms (2)

DEXTENZA Group

EXPERIMENTAL

Patients with Pterygium DEXTENZA Group

Drug: Dexamethasone Intracanalicular Insert, 0.4mg

Topical Prednisolone Acetate 1% Group

EXPERIMENTAL

Patients with Pterygium Topical Prednisolone Acetate 1% Group

Drug: Prednisolone Acetate 1%

Interventions

Dexamethasone Intracanalicular Insert, 0.4mg DRUG

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

DEXTENZA Group

Prednisolone Acetate 1% DRUG

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

Topical Prednisolone Acetate 1% Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of at least 18 years with primary pterygia

You may not qualify if:

• 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

Sponsors & Collaborators

• Michelle Rhee MD: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

New York Eye Specialists

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 38305478 DERIVED

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Officials

• Michelle K Rhee, MD

  New York Eye Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 27, 2020
• Study Start: October 1, 2020
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

US (1)