Dry EyePhase 4NCT04172961
Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days
A Phase 4 study testing nanomicellular cyclosporine 0.09% and Lifitegrast in people with Dry Eye, run by Toyos Clinic at 1 site in United States.
Trial summary
This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- nanomicellular cyclosporine 0.09% and Lifitegrast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 1 Dec 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is able to read, understand and sign informed consent.
- Provision of signed and dated informed consent and HIPAA authorization .
- Willingness to comply with study procedures and availabilty for duration of study.
- Aged 18-85, male or female
- Minimum of 5 central corneal superficial punctate keratitis spots.
- Normal eyelid anatomy
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- highly effective contraception for at least 1 month prior to screening and agreement to use effective contraception during study participation and for an additional 4 weeks after study drug discontinuation.
- Postmenopausal or surgical sterilization.
- -
Who cannot join
- Known hypersensitivity or contraindication to investigational product.
- Contact lens use within one month prior to screening
- Unwilling to discontinue contact lens.
- pregnancy or lactation.
- topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from same.
- Ocular surgery or eyelid surgery within 6 months prior to screening
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- Subjects can be on the following medications if they have been on a stable dose for 12 weeks: loteprednol, tetracycline, omega 3, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressives including oral steroids, non-steroidals, antihistamines, mast cell stabilizers, punctal plugs, corticotropin repository or glaucoma medications.
- abstain from eyelast growth products containing prostaglandin
- Must not have had penetrating intraocular surgery, refractive surgery, cornea transplant, eyelid surgery within 6 months prior to Visit 1
- Febrile illness within 1 week
- Treatment with another investigational drug or intervention within one month
- History of herpetic keratitis.
- Serious or severe disease or uncontrolled medical condition that in the judgment of the investigator could confound study study assessments or limit compliance.
- Use of new prescription eyedrop within 90 days of screening.
- Change in systemic medication within 90 days of screening
- Anticipated relocation or extensive travel during study period. -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Toyos Clinic
Nashville, Tennessee, 37215
Rachel McQuiddy, 615-327-4015, rmcquiddy@toyosclinic.com
Melissa Toyos, MD, 6153274015, mtoyos@toyosclinic.com
About this study
Official title: A Phase 4 Study to Assess the Clinical Efficacy of Nanomicellular Cyclosporine 0.09% Versus Lifitegrast 5.0% for Central Corneal Stain Clearing Over 90 Days
This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery.
Read the detailed description
The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.
- Conditions
- Dry Eye
- Being tested
- nanomicellular cyclosporine 0.09%, Lifitegrast
- 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.
nanomicellular cyclosporine 0.09%Drug
Also called Cequa
topical ophthalmic drop prior to elective surgery for eligible patients
LifitegrastDrug
Also called Xiidra
topical ophthalmic drop prior to elective surgery for eligible patients
| Study group | Role | What they receive |
|---|---|---|
| Nanomicellular Cyclosporine 0.09 prior to surgery | Experimental | 50 subjects receive nanomicellular cyclosporien 0.09% prior to elective ophthalmic surgery Receives: Drug: nanomicellular cyclosporine 0.09% |
| Lifitegrast 5.0% | Active comparator | 50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery Receives: Drug: Lifitegrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in central corneal staining
use of fluorescein staining to count at slit lamp actual number of central cornea spk
Measured: 90 days
Secondary outcomes (3)
change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning
subjective improvement of symptoms and assessment of adverse events
Measured: 90 days
change in corneal topography
variation in measurements of corneal topography
Measured: 90 days
change in Schirmers testing
change in Schirmers testing
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Feb 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toyos Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172961
- Sponsor's protocol ID
- SUNTC-001
- Status last verified
- Oct 2022
- First submitted
- 18 Nov 2019
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual date with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Study to Assess the Clinical Efficacy of Nanomicellular Cyclosporine 0.09% Versus Lifitegrast 5.0% for Central Corneal Stain Clearing Over 90 Days
- ClinicalTrials.gov ID
- NCT04172961
- Acronym / sponsor ID
- SUNTC-001
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Toyos ClinicUniversity, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 Nov 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.
This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery.
Detailed description
The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanomicellular Cyclosporine 0.09 prior to surgery | Experimental | Drug: nanomicellular cyclosporine 0.09%50 subjects receive nanomicellular cyclosporien 0.09% prior to elective ophthalmic surgery |
| Lifitegrast 5.0% | Active comparator | Drug: Lifitegrast50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is able to read, understand and sign informed consent.
- Provision of signed and dated informed consent and HIPAA authorization .
- Willingness to comply with study procedures and availabilty for duration of study.
- Aged 18-85, male or female
- Minimum of 5 central corneal superficial punctate keratitis spots.
Key exclusion criteria (16 listed)
- Known hypersensitivity or contraindication to investigational product.
- Contact lens use within one month prior to screening
- Unwilling to discontinue contact lens.
- pregnancy or lactation.
- topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from same.
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 |
|---|---|---|
| nanomicellular cyclosporine 0.09%Also: Cequatopical ophthalmic drop prior to elective surgery for eligible patients | Drug | Nanomicellular Cyclosporine 0.09 prior to surgery |
| LifitegrastAlso: Xiidratopical ophthalmic drop prior to elective surgery for eligible patients | Drug | Lifitegrast 5.0% |
Primary outcome
change in central corneal staining
Time frame: 90 days
use of fluorescein staining to count at slit lamp actual number of central cornea spk
3 secondary outcomes
change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning
Time frame: 90 days
change in corneal topography
Time frame: 90 days
change in Schirmers testing
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No. No plan to share individual date with other researchers
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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.
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 nanomicellular cyclosporine 0.09% and Lifitegrast in people with Dry Eye, run by Toyos Clinic 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 9 inclusion and 16 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 20 Oct 2022. 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 Rachel McQuiddy (6153274015, rmcquiddy@toyosclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in central corneal staining (time frame: 90 days). 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 20 Oct 2022.