Dry Eye Syndromes
Conditions
Brief summary
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%.
Detailed description
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.
Interventions
sustained released dexamethasone, 0.4mg
DRUGPrednisolone Acetate
Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.
Sponsors
Ocular Therapeutix, Inc.
Sight Medical Doctors PLLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Demonstrate objective signs of Boderline/ Mild Ocular Surface Disease (OSD) \[defined as mild symptoms, mild conjunctival staining (\<2+ Superficial Punctate Keratitis), Tear Break-up Time \<12s\] or demonstrate symptoms of OSD determined by SPEED questionnaire (SPEED Score \<10). 2. Nucleus sclerosis up to 2+ planning to undergo FLACS + Premium PCIOL in both eyes. 3. Ability to provide informed consent for procedures 4. Ability to attend scheduled follow up visits 5. No other corneal pathology to create unknown variability
Exclusion criteria
1. Age less than 18 2. Pregnancy/currently breast-feeding 3. Inability to provide informed consent 4. Documented adverse reaction to steroid (e.g. steroid responder, allergy, etc) 5. Punctal stenosis 6. Previous corneal transplant surgery or refractive surgery 7. Concurrent use of topical steroid eye drops 8. Systemic, topical or intravitreal steroid use within 1 month of baseline 9. Active history of chronic or recurrent inflammatory eye disease in either eye 10. History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus) 11. History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing 12. Diagnosis of Glaucoma or use of topical glaucoma drops 13. Participation in other studies in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) | Baseline, Post-Operative Day 7 and Day 30 | As measured by Best Corrected Visual Acuity (BCVA) from baseline and at 1 week and 30 days after surgery |
| Mean change in uncorrected Visual Acuity (VA) | Baseline, Post-Operative Day 7 and Day 30 | As measured by uncorrected VA from baseline and at 1 week and 30 days after surgery |
| Mean change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED) score | Baseline, Post-Operative Day 7 and Day 30 | As measured by SPEED score from baseline and at 1 week and 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with vision at 1 week and 30 days after surgery | Post-Operative Day 7 and Day 30 | As measured by patient satisfaction survey |
| Mean number of artificial tear drops dosed per day | 30 Day tear log. | As measured by patient daily log. |
| Mean change in tear break-up time (TBUT) | Baseline and at POD 7 and POD 30 | As measured by TBUT |
| Mean change in tear osmolarity | Baseline and at POD 7 and POD 30 | As measured by tear osmolarity |
| Mean change in corneal staining | Baseline and at POD 7 and POD 30 | As measured by corneal staining |
| Mean change from baseline in (Central Subfield Thickness) CST | Post-Operative Day 7 and 30 | As measured by CST |
Countries
United States
Contacts
Primary ContactJohn Passarelli, MD
Backup ContactMarshel Singleton, MSN, FNP
Outcome results
None listed