Dry Eye SyndromesPhase 4ACCURATENCT04237012

ACCURATE Study for Subjects With Dry Eyes

A Phase 4 study testing Dextenza 0.4Mg Intracanalicular Insert and Over the counter Artificial tears in people with Dry Eye Syndromes, run by The Eye Centers of Racine and Kenosha at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye Syndromes
What is being tested?: Dextenza 0.4Mg Intracanalicular Insert and Over the counter Artificial tears
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 16 Dec 2019to 30 Dec 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
Healthy volunteers accepted
Adult, Older adult

Inclusion Criteria:A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

Age 18 years and older
Demonstrate objective signs of Ocular Surface Disease (OSD) or
Demonstrate symptoms of OSD determined by a standardized questionnaire
No other corneal pathology to create unknown variability

Exclusion Criteria:A patient who meets any of the following criteria in either eye will be excluded from the study:

History of using topical steroids or other anti-inflammatory drops within 6 months of the study
History of corticosteroid implant (Ozurdex or Iluvien) or intravitreal steroid use for macular disease in last 12 months
History or current use of oral steroids or immunosuppressants
Active ocular infection
History of HSV
History corneal refractive surgery
Uncontrolled Glaucoma

Trial locations and contacts

1 site in 1 country.

United States1 site

The Eye Center of Racine
Racine, Wisconsin, 53405

Other trials in United States

About this study

Official title: Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease

Read the detailed description

This study will evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert and patient administered artificial tears prn compared to patient administered artificial tears prn (control) in patients with bilateral ocular surface dry eye disease. The study is a self-controlled design and includes multiple objective, measureable, and quantifiable endpoints to best determine an objective response to treatment in patient eyes randomized to either the insert plus prn artificial tears or artificial tears prn control. To aid in ensuring best possible masking, DEXTENZA is best visualized with blue light and yellow filter and therefore visualization will not be assessed until final visit following all measures.

Conditions: Dry Eye Syndromes
Being tested: Dextenza 0.4Mg Intracanalicular Insert, Over the counter Artificial tears
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 Intracanalicular InsertDrug
Also called dexamethasone
all patients will receive Intracanalicular dexamethasone, 0.4mg insert lower punctum and able to use over the counter artificial tears PRN at patient discretion
Over the counter Artificial tearsOther
over the counter artificial tears PRN at patient discretion

Study groups in NCT04237012
Study group	Role	What they receive
Dextenza	Experimental	Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed Receives: Drug: Dextenza 0.4Mg Intracanalicular Insert
Over the counter Artificial tears	Active comparator	Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert Receives: Other: Over the counter Artificial tears

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine effect of dexamethasone insert over artificial tears
To determine the effect of dexamethasone insert plus over-the-counter artificial tears prn compared to over the counter artificial tears prn from Baseline at Week 2 (at 8 am, 12 pm and 4 pm) as measured by iTrace and IOL Master 700: and comfort of dry eyes using the OSDI scale and reading scores
Measured: 1 month

Secondary outcomes (1)

OSDI scores
comfort of dry eyes using the OSDI scale and reading scores, scores are from the SPEED questionnaire. scale from 0-3 0-Never 1- Sometime 2-Often 3-Constant for the symptoms
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 201930 Dec 2021

First posted22 Jan 2020
Study start16 Dec 2019
Primary completion30 Dec 2021
Study completion30 Dec 2021

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 (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04237012
Sponsor's protocol ID: WIRB Protocol # 20192595
Acronym: ACCURATE
Status last verified: Nov 2024
First submitted: 13 Jan 2020
Last updated: 29 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease
ClinicalTrials.gov ID: NCT04237012
Acronym / sponsor ID: ACCURATE / WIRB Protocol # 20192595
Conditions: Dry Eye Syndromes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: The Eye Centers of Racine and KenoshaUniversity, hospital or other
Study start: 16 Dec 2019 (actual)
Primary completion: 30 Dec 2021 (actual)
Study completion: 30 Dec 2021 (actual)
First posted: 22 Jan 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dextenza	Experimental	Drug: Dextenza 0.4Mg Intracanalicular InsertTreatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed
Over the counter Artificial tears	Active comparator	Other: Over the counter Artificial tearsControlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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 Intracanalicular InsertAlso: dexamethasoneall patients will receive Intracanalicular dexamethasone, 0.4mg insert lower punctum and able to use over the counter artificial tears PRN at patient discretion	Drug	Dextenza
Over the counter Artificial tearsover the counter artificial tears PRN at patient discretion	Other	Over the counter Artificial tears

Primary outcome

Determine effect of dexamethasone insert over artificial tears
Time frame: 1 month
To determine the effect of dexamethasone insert plus over-the-counter artificial tears prn compared to over the counter artificial tears prn from Baseline at Week 2 (at 8 am, 12 pm and 4 pm) as measured by iTrace and IOL Master 700: and comfort of dry eyes using the OSDI scale and reading scores

1 secondary outcome

OSDI scores
Time frame: 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.

Related trials for Dry Eye Syndromes

Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

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.

Inder P Singh, M.D. principal investigator

President

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 29 Nov 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine effect of dexamethasone insert over artificial tears (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04237012.

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 29 Nov 2024.