Dextenza in Pterygium Surgery

Pterygium Clinical Trial

Official title:

Dextenza in Pterygium Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403516
• Other study ID #: Dextenza in Pterygium Surgery
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: August 5, 2021

Study information

• Verified date: April 2022
• Source: New York Eye Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 5, 2021
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pterygium

Intervention

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

Locations

Country	Name	City	State
United States	New York Eye Specialists	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Michelle Rhee MD	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Post-Op Day 1
Primary	Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Week 1
Primary	Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Month 1
Primary	Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Month 3
Primary	Patient satisfaction-comfort and convenience	Assessed by patient reported questionnaire	Assessed on Month 6
Secondary	To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Week 1
Secondary	To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Month 1
Secondary	To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Month 2
Secondary	To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Month 3
Secondary	To compare the degree of conjunctival hyperemia	Assessed by clinical external photography	Assessed on Month 6
Secondary	Mean number of days for corneal re-epithelialization	As evaluated by slit lamp examination	Assessed on Post-Op Day 1
Secondary	Mean number of days for corneal re-epithelialization	As evaluated by slit lamp examination	Assessed on Week 1
Secondary	Mean number of days for corneal re-epithelialization	As evaluated by slit lamp examination	Assessed on Month 1
Secondary	Recurrence of pterygium	As measured by yes or no on recurrence; external eye examination	Assessed at Month 1
Secondary	Recurrence of pterygium	As measured by yes or no on recurrence; external eye examination	Assessed at Month 2
Secondary	Recurrence of pterygium	As measured by yes or no on recurrence; external eye examination	Assessed at Month 3
Secondary	Recurrence of pterygium	As measured by yes or no on recurrence; external eye examination	Assessed at Month 6