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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%.
This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, a total of 30 patients will be randomized into two groups:
Group 1: 15 patients will undergo bilateral FLACS + Premium PCIOL in separate days and will receive a 0.4mg dexamethasone intracanalicular insert at the days of each surgery.
Group 2: 15 patients will undergo bilateral FLACS + Premium PCIOL in separate days and will receive prednisolone acetate 1% QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen starting at the days of each surgery.
All patient eyes will receive Prolensa 0.07% ophthalmic solution QD for 4 weeks starting 3 days prior to surgery and Besivance 0.6% eye drops TID/starting 3 days prior to surgery.
Per enrolled eye, the study period will last for approximately 30 days after surgery, consisting of three postop follow-up visits (six total postop visits per patient). At Day 1, Day 7 and Day 30, primary and secondary endpoints will be assessed alongside standard-of-care procedures. SPEED questionnaire will be assessed by a masked survey administrator. Adjusting for enrollment period, the study will last a total of approximately 12 months, including submission for publication/ presentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextenza Arm | Experimental |
| |
| Prednisolone Acetate 1% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | sustained released dexamethasone, 0.4mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) | As measured by Best Corrected Visual Acuity (BCVA) from baseline and at 1 week and 30 days after surgery | Baseline, Post-Operative Day 7 and Day 30 |
| Mean change in uncorrected Visual Acuity (VA) | As measured by uncorrected VA from baseline and at 1 week and 30 days after surgery | Baseline, Post-Operative Day 7 and Day 30 |
| Mean change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED) score | As measured by SPEED score from baseline and at 1 week and 30 days after surgery | Baseline, Post-Operative Day 7 and Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with vision at 1 week and 30 days after surgery | As measured by patient satisfaction survey | Post-Operative Day 7 and Day 30 |
| Mean number of artificial tear drops dosed per day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Passarelli, MD | Contact | 6312314455 | msingleton@sightmd.com | |
| Marshel Singleton, MSN, FNP | Contact | 6312314455 | msingleton@sightmd.com |
| Name | Affiliation | Role |
|---|---|---|
| John Passarelli, MD | Sight Medical Doctors PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SightMD, LIASC | Recruiting | Brentwood | New York | 11717 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Prednisolone Acetate |
| Drug |
Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week. |
|
As measured by patient daily log.
| 30 Day tear log. |
| Mean change in tear break-up time (TBUT) | As measured by TBUT | Baseline and at POD 7 and POD 30 |
| Mean change in tear osmolarity | As measured by tear osmolarity | Baseline and at POD 7 and POD 30 |
| Mean change in corneal staining | As measured by corneal staining | Baseline and at POD 7 and POD 30 |
| Mean change from baseline in (Central Subfield Thickness) CST | As measured by CST | Post-Operative Day 7 and 30 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |