ENHANCE: Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL

Sponsor

Sight Medical Doctors PLLC (Other)

Overall Status

Recruiting

CT.gov ID

NCT04863742

Collaborator

Ocular Therapeutix, Inc. (Industry)

Enrollment

Location

Arms

5.2

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Dextenza 0.4Mg Ophthalmic Insert Drug: Prednisolone Acetate	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study

Anticipated Study Start Date :

Apr 26, 2021

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dextenza Arm	Drug: Dextenza 0.4Mg Ophthalmic Insert sustained released dexamethasone, 0.4mg
Active Comparator: Prednisolone Acetate 1%	Drug: Prednisolone Acetate Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.

Arm

Intervention/Treatment

Experimental: Dextenza Arm

Drug: Dextenza 0.4Mg Ophthalmic Insert

sustained released dexamethasone, 0.4mg

Active Comparator: Prednisolone Acetate 1%

Drug: Prednisolone Acetate

Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).
Nucleus sclerosis up to 2+ planning to undergo FLACS + Premium PCIOL in both eyes.
Ability to provide informed consent for procedures
Ability to attend scheduled follow up visits
No other corneal pathology to create unknown variability

Exclusion Criteria:

Age less than 18
Pregnancy/currently breast-feeding
Inability to provide informed consent
Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
Punctal stenosis
Previous corneal transplant surgery or refractive surgery
Concurrent use of topical steroid eye drops
Systemic, topical or intravitreal steroid use within 1 month of baseline
Active history of chronic or recurrent inflammatory eye disease in either eye
History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
Diagnosis of Glaucoma or use of topical glaucoma drops
Participation in other studies in the last 6 months