Dry Eye SyndromesPhase 4ENHANCENCT04863742
Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate in people with Dry Eye Syndromes, run by Sight Medical Doctors PLLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 30 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SightMD, LIASC
Brentwood, New York, 11717
John Passarelli, MD, 631-231-4455, msingleton@sightmd.com
Marshel Singleton, MSN, FNP, 6312314455, msingleton@sightmd.com
About this study
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
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%.
Read the 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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4Mg Ophthalmic InsertDrug
sustained released dexamethasone, 0.4mg
Prednisolone AcetateDrug
Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.
| Study group | Role | What they receive |
|---|---|---|
| Dextenza Arm | Experimental | Not described Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
| Prednisolone Acetate 1% | Active comparator | Not described Receives: Drug: Prednisolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline, Post-Operative Day 7 and Day 30
Secondary outcomes (6)
Patient satisfaction with vision at 1 week and 30 days after surgery
As measured by patient satisfaction survey
Measured: Post-Operative Day 7 and Day 30
Mean number of artificial tear drops dosed per day
As measured by patient daily log.
Measured: 30 Day tear log.
Mean change in tear break-up time (TBUT)
As measured by TBUT
Measured: Baseline and at POD 7 and POD 30
Mean change in tear osmolarity
As measured by tear osmolarity
Measured: Baseline and at POD 7 and POD 30
Mean change in corneal staining
As measured by corneal staining
Measured: Baseline and at POD 7 and POD 30
Mean change from baseline in (Central Subfield Thickness) CST
As measured by CST
Measured: Post-Operative Day 7 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start26 Apr 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sight Medical Doctors PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Principal investigator, Dr. John Passarelli, Sight Medical Doctors PLLC
- Investigators
- John Passarelli, MD, Principal investigator, Sight Medical Doctors PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863742
- Sponsor's protocol ID
- ENHANCE
- Acronym
- ENHANCE
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04863742
- Acronym / sponsor ID
- ENHANCE / ENHANCE
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sight Medical Doctors PLLCUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 26 Apr 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextenza Arm | Experimental | Drug: Dextenza 0.4Mg Ophthalmic Insert |
| Prednisolone Acetate 1% | Active comparator | Drug: Prednisolone Acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insertsustained released dexamethasone, 0.4mg | Drug | Dextenza Arm |
| Prednisolone AcetatePrednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week. | Drug | Prednisolone Acetate 1% |
Primary outcome
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
Time frame: 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)
Time frame: 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
Time frame: Baseline, Post-Operative Day 7 and Day 30
As measured by SPEED score from baseline and at 1 week and 30 days after surgery
6 secondary outcomes
Patient satisfaction with vision at 1 week and 30 days after surgery
Time frame: Post-Operative Day 7 and Day 30
Mean number of artificial tear drops dosed per day
Time frame: 30 Day tear log.
Mean change in tear break-up time (TBUT)
Time frame: Baseline and at POD 7 and POD 30
Mean change in tear osmolarity
Time frame: Baseline and at POD 7 and POD 30
Mean change in corneal staining
Time frame: Baseline and at POD 7 and POD 30
Mean change from baseline in (Central Subfield Thickness) CST
Time frame: Post-Operative Day 7 and 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Passarelli, MD principal investigator
Sight Medical Doctors PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate in people with Dry Eye Syndromes, run by Sight Medical Doctors PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Passarelli, MD (6312314455, msingleton@sightmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) (time frame: Baseline, Post-Operative Day 7 and Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.