Dry EyePhase 4NCT04120987
Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra
A Phase 4 study testing Lifitegrast 5% Ophthalmic Solution in people with Dry Eye, run by Bucci Laser Vision Institute at 1 site in United States.
Trial summary
To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Lifitegrast 5% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2021to 25 Jun 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Positive for MMP-9 bilaterally as assessed by the Inflammadry assay
Who cannot join
- Negative Inflammadry assay in either eye
- Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation
- Ocular surface diseases that might confound the interpretation of the InflammaDry assay
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra
To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.
Read the detailed description
Single-center, prospective, randomized, investigator-initiated study
250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay
Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra
The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.
- Conditions
- Dry Eye
- Being tested
- Lifitegrast 5% Ophthalmic Solution
- Keywords
- cataract, lifitegrast, dry eye syndrome, ocular surface inflammation, hyperosmolarity, MMP-9
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifitegrast 5% Ophthalmic SolutionDrug
BID OU
| Study group | Role | What they receive |
|---|---|---|
| Lifitegrast | Active comparator | One drop of Lifitegrast Ophthalmic Solution 5% will be instilled into each eye twice daily (approximately 12 hours apart) using a single-use conainer. Receives: Drug: Lifitegrast 5% Ophthalmic Solution |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start31 May 2021
- Primary completion25 Jun 2022
- Study completion25 Jun 2022
Why it stopped: Administrative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucci Laser Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank A Bucci, Jr., MD, Principal investigator, Bucci Laser Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120987
- Sponsor's protocol ID
- IIR-USA-002133
- Status last verified
- Jul 2023
- First submitted
- 25 Sep 2019
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra
- ClinicalTrials.gov ID
- NCT04120987
- Acronym / sponsor ID
- IIR-USA-002133
- Conditions
- Dry Eye
- Keywords
- cataract, lifitegrast, dry eye syndrome, ocular surface inflammation, hyperosmolarity, MMP-9
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bucci Laser Vision InstituteUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 9 Oct 2019 (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.
To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.
Detailed description
Single-center, prospective, randomized, investigator-initiated study
250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay
Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra
The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifitegrast | Active comparator | Drug: Lifitegrast 5% Ophthalmic SolutionOne drop of Lifitegrast Ophthalmic Solution 5% will be instilled into each eye twice daily (approximately 12 hours apart) using a single-use conainer. |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive for MMP-9 bilaterally as assessed by the Inflammadry assay
Key exclusion criteria (3 listed)
- Negative Inflammadry assay in either eye
- Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation
- Ocular surface diseases that might confound the interpretation of the InflammaDry assay
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 |
|---|---|---|
| Lifitegrast 5% Ophthalmic SolutionBID OU | Drug | Lifitegrast |
Primary outcome
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
Time frame: 12 weeks
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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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.
Frank A Bucci, Jr., MD principal investigator
Bucci Laser Vision
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 Lifitegrast 5% Ophthalmic Solution in people with Dry Eye, run by Bucci Laser Vision Institute 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 27 Jul 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra (time frame: 12 weeks). 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 27 Jul 2023.