A Phase 4 interventional study of Cyclosporine ophthalmic solution, 0.1% and Saline solution, 0.6% in Dry Eye Disease and Endothelial Cell, sponsored by Novaliq GmbH. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Novaliq GmbH · Phase 4, Interventional, and Treatment
Among 45 studies testing cyclosporine in Dry Eye Syndromes — 5 open to participants now, 5 under way, none of them phase 3. Cyclosporine · Dry Eye Syndromes.
Among the 45 studies testing cyclosporine in Dry Eye Syndromes, this one is the 4th largest by enrollment of the 41 interventional ones, is one of 2 that started in 2024, is one of 23 in phase 4, and was the 36th registered.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 204 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →5 of the 45 studies testing cyclosporine in Dry Eye Syndromes are open now, in 2 countries. Each count lists the studies.
Cyclosporine: first FDA approval 1983 (SANDIMMUNE), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →45 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2024.
Median enrollment 51 across the 41 interventional studies. Of the 35 that completed or were terminated, 11 (31%) have results posted.
19 of 45 have an industry lead sponsor. The 10 most frequent:
Novaliq GmbH is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
11 studies in Dry Eye Syndromes by Novaliq GmbH: none open now, none under way, none of them phase 3. Of 11 finished, 6 (55%) have results posted.
Among the 11 studies in Dry Eye Syndromes by Novaliq GmbH, this one is the only one that started in 2024, is the only one in phase 4, and was the 11th registered.
Novaliq GmbH’s Dry Eye Syndromes studies by the year they started, since 2013.
5 of the studies testing cyclosporine in Dry Eye Syndromes that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06898853The University of New South WalesThe Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes | 2026-12-30 |
| NCT07553455Canyon City EyecareVevye + Flarex Combination Therapy for Dry Eye | 2026-12-31 |
| NCT07224529University of Alabama at BirminghamEfficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction | 2027-02-01 |
| NCT07904728Ocular Aesthetics, LLC dba Ocular Clinical TrialsTreating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution | 2027-03-15 |
| NCT07368595Baylor College of MedicineComparison of Conjunctival Goblet Cell Density in Dry Eye Patients Treated With Cyclosporine 0.1% Dissolved in Perfluorobutylpentane (Vevye®) or Generic 0.05% Cyclosporine Emulsion for 8 Weeks | 2027-03-31 |
Among the 45 studies testing cyclosporine in Dry Eye Syndromes, from their registry updates:
Among Novaliq GmbH’s 11 in Dry Eye Syndromes:
Nothing recorded among them since 2026-09-25.
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)
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cyclosporine ophthalmic solution, 0.1%; 12 months
Drug: Cyclosporine ophthalmic solution, 0.1%
Saline solution, 0.6%; 12 months
Drug: Saline solution, 0.6%
Colorless and clear opthalmic solution containing 0.1% Cyclosporine
Also known as: VEVYE
Colorless and clear sodium chloride solution (0.6%)
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
Time frame: 12 months
| Milestone | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% |
|---|---|---|
| Started | 135 | 69 |
| Completed | 122 | 61 |
| Not completed | 13 | 8 |
Change from baseline at 12 months in ECD measured as count/mm2 using specular microscopy in the study eye
| cells/mm² | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% |
|---|---|---|
| Change From Baseline in Corneal Endothelial Cell Density (ECD) | 6.4 ± 90.47 | -1.0 ± 81.43 |
Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | 0/135 (0%) | 5/135 (3.7%) | 27/135 (20%) |
| Saline Solution, 0.6% | 0/69 (0%) | 2/69 (2.9%) | 13/69 (18.8%) |
| Event | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% |
|---|---|---|
| Worsening of coronary artery diseaseCardiac disorders | 0/135 | 1/69 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/135 | 1/69 |
| Mild Acute PancreatitisGastrointestinal disorders | 1/135 | 0/69 |
| AnemiaBlood and lymphatic system disorders | 1/135 | 0/69 |
| LymphadenitisBlood and lymphatic system disorders | 1/135 | 0/69 |
| Pain secondary to posterolateral lumbar fusion surgeryMusculoskeletal and connective tissue disorders | 1/135 | 0/69 |
| Worsening OsteoarthritisMusculoskeletal and connective tissue disorders | 1/135 | 0/69 |
| Event | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% |
|---|---|---|
| Application site irritationGeneral disorders | 20/135 | 7/69 |
| HypertensionVascular disorders | 7/135 | 6/69 |
| Age, Categorical(Participants) | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 74 | 43 | 117 |
| >=65 years | 61 | 26 | 87 |
| Sex: Female, Male(Participants) | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% | Total |
|---|---|---|---|
| Female | 105 | 50 | 155 |
| Male | 30 | 19 | 49 |
| Ethnicity (NIH/OMB)(Participants) | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 10 | 17 |
| Not Hispanic or Latino | 128 | 59 | 187 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% | Total |
|---|---|---|---|
| United States | 135 | 69 | 204 |
| Corneal Endothelial Cell Density(cell/mm²) | Cyclosporine Ophthalmic Solution, 0.1% (VEVYE) | Saline Solution, 0.6% | Total |
|---|---|---|---|
| Mean | 2488.6 ± 283.32 | 2507.7 ± 250.23 | 2495.0 ± 272.11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2024 to primary completion in Jul 2025, 15 months.
Results were first posted in Aug 2026, 1 year after primary completion.
Of 28 industry-sponsored phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 15. This study's 15 months is above that.
Counting every sponsor, half of 112 studies reached it within 12 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cyclosporine
Novaliq GmbH