Dry Eye DiseasePhase 4NCT06329661
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
A Phase 4 study testing Cyclosporine ophthalmic solution, 0.1% and Saline solution, 0.6% in people with Dry Eye Disease and Endothelial Cell, run by Novaliq GmbH at 6 sites in United States.
Trial summary
The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease, Endothelial Cell
- What is being tested?
- Cyclosporine ophthalmic solution, 0.1% and Saline solution, 0.6%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 Apr 2024to 30 Jul 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be at least 18 years of age;
- Provide written informed consent;
- Have a subject reported history of dry eye disease (DED) in both eyes
- Be able and willing to follow instructions, including participation in all trial assessments and visits.
Who cannot join
- Be a woman who is pregnant, nursing, or planning a pregnancy;
- Unwillingness to to use acceptable means of birth control
- Clinically significant slit-lamp findings or abnormal lid anatomy at screening
- Ongoing ocular or systemic infection at screening or baseline
- Presence of uncontrolled systemic diseases
- Presence of known allergy and/or sensitivity to the study drug or its components
Show all 9Show fewer
- Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period
- Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly.
- Randomized in a previous CyclASol trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
CYS-007 Investigational Site
Cranberry Township, Pennsylvania, 16066
CYS-007 Investigational Site
Garner, North Carolina, 27529
CYS-007 Investigational Site
Memphis, Tennessee, 38120
CYS-007 Investigational Site
Newport Beach, California, 92663
CYS-007 Investigational Site
Shelby, North Carolina, 28150
CYS-007 Investigational Site
Torrance, California, 90505
About this study
Official title: A Multi-center, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Corneal Endothelial Health of Dry Eye Disease Subjects Treated With Cyclosporine Ophthalmic Solution, 0.1%
The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)
Read the detailed description
The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.
- Conditions
- Dry Eye Disease, Endothelial Cell
- Being tested
- Cyclosporine ophthalmic solution, 0.1%, Saline solution, 0.6%
- 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.
Cyclosporine ophthalmic solution, 0.1%Drug
Also called VEVYE
Colorless and clear opthalmic solution containing 0.1% Cyclosporine
Saline solution, 0.6%Drug
Colorless and clear sodium chloride solution (0.6%)
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine ophthalmic solution, 0.1% (VEVYE) | Active comparator | Cyclosporine ophthalmic solution, 0.1%; 12 months Receives: Drug: Cyclosporine ophthalmic solution, 0.1% |
| Saline solution, 0.6% | Placebo comparator | Saline solution, 0.6%; 12 months Receives: Drug: Saline solution, 0.6% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Corneal Endothelial Cell Density (ECD)
Change from baseline at 12 months in ECD measured as count/mm2 using specular microscopy in the study eye
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start22 Apr 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novaliq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonja Krösser, PhD, Study director, Novaliq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329661
- Sponsor's protocol ID
- CYS-007
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2024
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Corneal Endothelial Health of Dry Eye Disease Subjects Treated With Cyclosporine Ophthalmic Solution, 0.1%
- ClinicalTrials.gov ID
- NCT06329661
- Acronym / sponsor ID
- CYS-007
- Conditions
- Dry Eye Disease, Endothelial Cell
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Novaliq GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Posted 19 Aug 2026
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 trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)
Detailed description
The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine ophthalmic solution, 0.1% (VEVYE) | Active comparator | Drug: Cyclosporine ophthalmic solution, 0.1%Cyclosporine ophthalmic solution, 0.1%; 12 months |
| Saline solution, 0.6% | Placebo comparator | Drug: Saline solution, 0.6%Saline solution, 0.6%; 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age;
- Provide written informed consent;
- Have a subject reported history of dry eye disease (DED) in both eyes
- Be able and willing to follow instructions, including participation in all trial assessments and visits.
Key exclusion criteria (9 listed)
- Be a woman who is pregnant, nursing, or planning a pregnancy;
- Unwillingness to to use acceptable means of birth control
- Clinically significant slit-lamp findings or abnormal lid anatomy at screening
- Ongoing ocular or systemic infection at screening or baseline
- Presence of uncontrolled systemic diseases
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 |
|---|---|---|
| Cyclosporine ophthalmic solution, 0.1%Also: VEVYEColorless and clear opthalmic solution containing 0.1% Cyclosporine | Drug | Cyclosporine ophthalmic solution, 0.1% (VEVYE) |
| Saline solution, 0.6%Colorless and clear sodium chloride solution (0.6%) | Drug | Saline solution, 0.6% |
Primary outcome
Change From Baseline in Corneal Endothelial Cell Density (ECD)
Time frame: 12 months
Change from baseline at 12 months in ECD measured as count/mm2 using specular microscopy in the study eye
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sonja Krösser, PhD study director
Novaliq GmbH
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine ophthalmic solution, 0.1% and Saline solution, 0.6% in people with Dry Eye Disease and Endothelial Cell, run by Novaliq GmbH at 6 sites 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 4 inclusion and 9 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Corneal Endothelial Cell Density (ECD) (time frame: 12 months). 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 19 Aug 2026.