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To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery.
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week.
Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Dextenza |
|
| Group B | Active Comparator | Topical Prednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference | As measured by COMTOL adapted survey. | Through Month 1 (Day 28 +/- 3 days) |
| Patient Comfort | As measured by SPEED Questionnaire. | Through Month 1 (Day 28 +/- 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Health | As measured by corneal staining. | Through Month 1 (Day 28 +/- 3 days) |
| Visual Outcomes | As measured by uncorrected Visual Acuity. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints | As measured by intraocular pressure increase of 10 mm Hg or greater from baseline. | Through Month 1 (Day 28 +/- 3 days) |
| Safety Endpoints | As measured by proportion of eyes rescued with additional topical prednisolone treatment or increased frequency of dosing. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision ND | Recruiting | West Fargo | North Dakota | 58078 | United States |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Topical Prednisolone | Drug | Standard of care topical drop treatment |
|
| Through Month 1 (Day 28 +/- 3 days) |
| Ocular Pain | As measured by Ocular Pain Assessment. | Through Month 1 (Day 28 +/- 3 days) |
| Through Month 1 (Day 28 +/- 3 days) |
| Safety Endpoints | As measured by occurrence of adverse events. | Through Month 1 (Day 28 +/- 3 days) |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |