Pterygium
Conditions
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.
Interventions
DRUGDexamethasone 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.
To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.
Sponsors
Ocular Therapeutix, Inc.
Michelle Rhee MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction-comfort and convenience | Assessed on Post-Op Day 1 | Assessed by patient reported questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the degree of conjunctival hyperemia | Assessed on Week 1 | Assessed by clinical external photography |
| Mean number of days for corneal re-epithelialization | Assessed on Post-Op Day 1 | As evaluated by slit lamp examination |
| Recurrence of pterygium | Assessed at Month 1 | As measured by yes or no on recurrence; external eye examination |
Countries
United States
Outcome results
None listed