Graft-versus-host-diseaseEarly Phase 1NCT04792580
The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease
A Early Phase 1 study testing Lifitegrast 5% Ophthalmic Solution in people with Graft-versus-host-disease and Ocular Graft-versus-host Disease, run by Richard W Yee, MD at 1 site in United States.
Trial summary
The objective of this study is to evaluate the clinical efficacy of 5% lifitegrast ophthalmic solution in subjects with dry eye disease secondary to ocular Graft-versus-Host Disease compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Graft-versus-host-disease, Ocular Graft-versus-host Disease
- What is being tested?
- Lifitegrast 5% Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2022to 30 Apr 2024
- Phase
- Early Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SANDE questionnaire >40 mm
- Schirmer test without anesthesia >2 mm and <10mm across 5 minutes
- Tear film break-up time (TFBUT) < 10 seconds in the worse eye
- The same eye (eligible eye) must fulfill all the above criteria
- Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units (20/200 Snellen value) in both eyes at the time of study enrollment.
- If a female of childbearing potential, have a negative pregnancy test.
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- Only patients who satisfy all Informed Consent requirements may be included in the study. The patient must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients must have been approved by the Institutional Review Board (IRB) / Independent Ethics Committee (IEC) for the current study.
- Patients must have the ability and willingness to comply with study procedures.
- Patients must meet the internationally established criteria for a "probable" or "definite" diagnosis of oGVHD. As an inclusion criterion, a diagnosis of oGVHD is established from the Schirmer's 1 tear test, corneal fluorescein staining, OSDI scores, and conjunctival injection. Severity scores are assigned according to the panels provided by the International Chronic Ocular Graft-versus-Host Disease Consensus Group.
- Ability to speak and understand the English language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
Who cannot join
- Evidence of an active ocular infection, in either eye
- Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study
- History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than dry eye
- Intraocular inflammation defined as Tyndall score >0
- Systemic disease (excluding GVHD) not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, thyroid malfunction..) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or with a condition incompatible with the frequent assessment required by the study
- Patient had a serious adverse reaction or significant hypersensitivity to any drug or chemically-related compounds or had a clinically significant allergy to drugs, foods, amide local anesthetics or other materials including commercial artificial tears (in the opinion of the investigator)
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- Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
- are currently pregnant or,
- have a positive result at the urine pregnancy test (Baseline/Day 0) or,
- intend to become pregnant during the study treatment period or,
- are breast-feeding or,
- are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or Intra Uterine Device (IUD) - during the entire course of, and 30 days after, the study treatment periods
- Any concurrent medical condition, that in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
- Use of topical cyclosporine, topical corticosteroids or any other topical drug for the treatment of dry eye in either eye within 30 days prior to study enrollment.
- Contact lenses or punctum plug use at any time 30 days prior to or during the study
- History of drug addiction or alcohol abuse
- Any prior ocular surgery (including refractive palpebral and cataract surgery) if within 90 days before the screening visit
- Participation in a trial with a new active substance during the past 6 months
- Participation in another trial study at the same time as the present study.
- Previous use of lifitegrast, 5%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center Randomized Double-Masked Placebo-Controlled Parallel-Group, Study of the Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease
The objective of this study is to evaluate the clinical efficacy of 5% lifitegrast ophthalmic solution in subjects with dry eye disease secondary to ocular Graft-versus-Host Disease compared to placebo.
- Being tested
- Lifitegrast 5% Ophthalmic Solution, Placebo
- Keywords
- Ocular surface, Bone marrow transplant, stem cell transplant, ocular Graft-versus-Host Disease, GVHD
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifitegrast 5% Ophthalmic SolutionDrug
Used twice a day in both eyes for 4 weeks after a 2 week washout.
PlaceboDrug
Used twice a day in both eyes for 4 weeks after a 2 week washout with the same drops.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects receive lifitegrast 5% ophthalmic solution twice a day for 4 weeks after a 2 week washout. Receives: Drug: Lifitegrast 5% Ophthalmic Solution |
| Placebo | Placebo comparator | Subjects receive the lifitegrast vehicle as placebo twice a day for 4 weeks after a 2 week washout. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Symptoms questionnaire (SANDE) scores to Week 4
The SANDE score is calculated by taking the square root of the product of the severity of symptoms scores and the frequency of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount or absence of dry eye symptoms.
Measured: Baseline to Week 4
Secondary outcomes (1)
Change from baseline in Schirmer I test (without anesthesia) to Week 4
Without previously instilling anesthetic drops, the Schirmer strip will be inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding contact with the cornea.
The patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start22 Oct 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-versus-host-diseaseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard W Yee, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Richard W Yee, MD, Yee, Richard W., M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792580
- Sponsor's protocol ID
- CLIF606A1US09T
- Status last verified
- Jul 2024
- First submitted
- 8 Mar 2021
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Randomized Double-Masked Placebo-Controlled Parallel-Group, Study of the Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease
- ClinicalTrials.gov ID
- NCT04792580
- Acronym / sponsor ID
- CLIF606A1US09T
- Keywords
- Ocular surface, Bone marrow transplant, stem cell transplant, ocular Graft-versus-Host Disease, GVHD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Richard W Yee, MDUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 11 Mar 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.
The objective of this study is to evaluate the clinical efficacy of 5% lifitegrast ophthalmic solution in subjects with dry eye disease secondary to ocular Graft-versus-Host Disease compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Lifitegrast 5% Ophthalmic SolutionSubjects receive lifitegrast 5% ophthalmic solution twice a day for 4 weeks after a 2 week washout. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects receive the lifitegrast vehicle as placebo twice a day for 4 weeks after a 2 week washout. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- SANDE questionnaire >40 mm
- Schirmer test without anesthesia >2 mm and <10mm across 5 minutes
- Tear film break-up time (TFBUT) < 10 seconds in the worse eye
- The same eye (eligible eye) must fulfill all the above criteria
- Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units (20/200 Snellen value) in both eyes at the time of study enrollment.
Key exclusion criteria (20 listed)
- Evidence of an active ocular infection, in either eye
- Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study
- History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than dry eye
- Intraocular inflammation defined as Tyndall score >0
- Systemic disease (excluding GVHD) not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, thyroid malfunction..) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or with a condition incompatible with the frequent assessment required by the study
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 SolutionUsed twice a day in both eyes for 4 weeks after a 2 week washout. | Drug | Treatment |
| PlaceboUsed twice a day in both eyes for 4 weeks after a 2 week washout with the same drops. | Drug | Placebo |
Primary outcome
Change from baseline in Symptoms questionnaire (SANDE) scores to Week 4
Time frame: Baseline to Week 4
The SANDE score is calculated by taking the square root of the product of the severity of symptoms scores and the frequency of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount or absence of dry eye symptoms.
1 secondary outcome
Change from baseline in Schirmer I test (without anesthesia) to Week 4
Time frame: Baseline to Week 4
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 15 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lifitegrast 5% Ophthalmic Solution in people with Graft-versus-host-disease and Ocular Graft-versus-host Disease, run by Richard W Yee, MD 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 10 inclusion and 20 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: finished, as of the sponsor's last update on 15 Jul 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change from baseline in Symptoms questionnaire (SANDE) scores to Week 4 (time frame: Baseline to Week 4). 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 15 Jul 2024.