A Phase 4 interventional study of Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate in Dry Eye Syndromes, sponsored by Sight Medical Doctors PLLC. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Sight Medical Doctors PLLC · Phase 4, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Sight Medical Doctors PLLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Dextenza 0.4Mg Ophthalmic Insert
Drug: Prednisolone Acetate
sustained released dexamethasone, 0.4mg
Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.
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
Time frame: 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
Time frame: 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
Time frame: Baseline, Post-Operative Day 7 and Day 30
Patient satisfaction with vision at 1 week and 30 days after surgery
As measured by patient satisfaction survey
Time frame: Post-Operative Day 7 and Day 30
Mean number of artificial tear drops dosed per day
As measured by patient daily log.
Time frame: 30 Day tear log.
Mean change in tear break-up time (TBUT)
As measured by TBUT
Time frame: Baseline and at POD 7 and POD 30
Mean change in tear osmolarity
As measured by tear osmolarity
Time frame: Baseline and at POD 7 and POD 30
Mean change in corneal staining
As measured by corneal staining
Time frame: Baseline and at POD 7 and POD 30
Mean change from baseline in (Central Subfield Thickness) CST
As measured by CST
Time frame: Post-Operative Day 7 and 30
Start is estimated for Apr 2021; primary completion for Jul 2021, 3 months later.
Of 81 non-industry phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's planned 3 months is below that.
Counting every sponsor, half of 111 studies reached it within 13 months; a quarter within 5 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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