Clinical trial NCT04403516: Dextenza in Pterygium Surgery
Official title: Dextenza in Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pterygium
Lead sponsor: New York Eye Specialists
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient satisfaction-comfort and convenience
timeFrame: Assessed on Post-Op Day 1
measure: Patient satisfaction-comfort and convenience
timeFrame: Assessed on Week 1
measure: Patient satisfaction-comfort and convenience
timeFrame: Assessed on Month 1
measure: Patient satisfaction-comfort and convenience
timeFrame: Assessed on Month 3
measure: Patient satisfaction-comfort and convenience
timeFrame: Assessed on Month 6
Secondary outcomes:
measure: To compare the degree of conjunctival hyperemia
timeFrame: Assessed on Week 1
measure: To compare the degree of conjunctival hyperemia
timeFrame: Assessed on Month 1
measure: To compare the degree of conjunctival hyperemia
timeFrame: Assessed on Month 2
measure: To compare the degree of conjunctival hyperemia
timeFrame: Assessed on Month 3
measure: To compare the degree of conjunctival hyperemia
timeFrame: Assessed on Month 6
measure: Mean number of days for corneal re-epithelialization
timeFrame: Assessed on Post-Op Day 1
measure: Mean number of days for corneal re-epithelialization
timeFrame: Assessed on Week 1
measure: Mean number of days for corneal re-epithelialization
timeFrame: Assessed on Month 1
measure: Recurrence of pterygium
timeFrame: Assessed at Month 1
measure: Recurrence of pterygium
timeFrame: Assessed at Month 2
measure: Recurrence of pterygium
timeFrame: Assessed at Month 3
measure: Recurrence of pterygium
timeFrame: Assessed at Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Eye Specialists
state: New York
Study officials:
affiliation: New York Eye Specialists
name: Michelle K Rhee, MD
role: PRINCIPAL_INVESTIGATOR
References: