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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXTENZA Group | Experimental | Patients with Pterygium DEXTENZA Group |
|
| Topical Prednisolone Acetate 1% Group | Experimental | Patients with Pterygium Topical Prednisolone Acetate 1% Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Week 1 |
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle K Rhee, MD | New York Eye Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Eye Specialists | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38305478 | Derived | 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. |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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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.
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| Prednisolone Acetate 1% | Drug | To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery. |
|
| Assessed on Month 1 |
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Month 2 |
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Month 3 |
| To compare the degree of conjunctival hyperemia | Assessed by clinical external photography | Assessed on Month 6 |
| Mean number of days for corneal re-epithelialization | As evaluated by slit lamp examination | Assessed on Post-Op Day 1 |
| Mean number of days for corneal re-epithelialization | As evaluated by slit lamp examination | Assessed on Week 1 |
| Mean number of days for corneal re-epithelialization | As evaluated by slit lamp examination | Assessed on Month 1 |
| Recurrence of pterygium | As measured by yes or no on recurrence; external eye examination | Assessed at Month 1 |
| Recurrence of pterygium | As measured by yes or no on recurrence; external eye examination | Assessed at Month 2 |
| Recurrence of pterygium | As measured by yes or no on recurrence; external eye examination | Assessed at Month 3 |
| Recurrence of pterygium | As measured by yes or no on recurrence; external eye examination | Assessed at Month 6 |