Dextenza in Pterygium Surgery

• Sponsor: Michelle Rhee MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT04403516
• Collaborator: Ocular Therapeutix, Inc. (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.1
• Patients Per Site Per Month: 3

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Pterygium	Drug: Dexamethasone Intracanalicular Insert, 0.4mg; Drug: Prednisolone Acetate 1%	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Dextenza in Pterygium Surgery
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Aug 5, 2021
• Actual Study Completion Date: Aug 5, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction-comfort and convenience [Assessed on Post-Op Day 1]

   Assessed by patient reported questionnaire

2. Patient satisfaction-comfort and convenience [Assessed on Week 1]

   Assessed by patient reported questionnaire

3. Patient satisfaction-comfort and convenience [Assessed on Month 1]

   Assessed by patient reported questionnaire

4. Patient satisfaction-comfort and convenience [Assessed on Month 3]

   Assessed by patient reported questionnaire

5. Patient satisfaction-comfort and convenience [Assessed on Month 6]

   Assessed by patient reported questionnaire

Secondary Outcome Measures

1. To compare the degree of conjunctival hyperemia [Assessed on Week 1]

   Assessed by clinical external photography

2. To compare the degree of conjunctival hyperemia [Assessed on Month 1]

   Assessed by clinical external photography

3. To compare the degree of conjunctival hyperemia [Assessed on Month 2]

   Assessed by clinical external photography

4. To compare the degree of conjunctival hyperemia [Assessed on Month 3]

   Assessed by clinical external photography

5. To compare the degree of conjunctival hyperemia [Assessed on Month 6]

   Assessed by clinical external photography

6. Mean number of days for corneal re-epithelialization [Assessed on Post-Op Day 1]

   As evaluated by slit lamp examination

7. Mean number of days for corneal re-epithelialization [Assessed on Week 1]

   As evaluated by slit lamp examination

8. Mean number of days for corneal re-epithelialization [Assessed on Month 1]

   As evaluated by slit lamp examination

9. Recurrence of pterygium [Assessed at Month 1]

   As measured by yes or no on recurrence; external eye examination

10. Recurrence of pterygium [Assessed at Month 2]

    As measured by yes or no on recurrence; external eye examination

11. Recurrence of pterygium [Assessed at Month 3]

    As measured by yes or no on recurrence; external eye examination

12. Recurrence of pterygium [Assessed at Month 6]

    As measured by yes or no on recurrence; external eye examination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Eye Specialists	New York	New York	United States	10016

Sponsors and Collaborators

• Michelle Rhee MD
• Ocular Therapeutix, Inc.

Investigators

• Principal Investigator: Michelle K Rhee, MD, New York Eye Specialists

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michelle Rhee MD, Principal Investigator, New York Eye Specialists
• ClinicalTrials.gov Identifier: NCT04403516
• Other Study ID Numbers: Dextenza in Pterygium Surgery
• First Posted: May 27, 2020
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• 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
• Additional relevant MeSH terms: Pterygium; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

No Results Posted as of Apr 6, 2022