A Phase 3 interventional study of CyclASol Ophthalmic Solution in Dry Eye Disease (DED), sponsored by Novaliq GmbH. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Novaliq GmbH · Phase 3, Interventional, and Treatment
Among 11 studies in Dry Eye Syndromes by Novaliq GmbH — none open to participants now, none under way, none of them phase 3. Dry Eye Syndromes · Novaliq GmbH.
Among the 11 studies in Dry Eye Syndromes by Novaliq GmbH, this one is the only one that started in 2021, is one of 2 in phase 3, and was the 8th registered.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 202 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →None of the 11 studies in Dry Eye Syndromes by Novaliq GmbH is open now.
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 →11 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2021.
Median enrollment 207 across the 7 interventional studies, 33 across the 4 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
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.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Dry Eye Syndromes by Novaliq GmbH, from their registry updates:
Nothing recorded among them since 2026-09-25.
The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.
Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 months.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cyclosporine A solution in vehicle
Drug: CyclASol Ophthalmic Solution
Cyclosporine A solution in vehicle
Number of Subjects Reporting Any Adverse Events
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed.
Time frame: 12 months
Single arm, open label
| Milestone | CyclASol Ophthalmic Solution |
|---|---|
| Started | 202 |
| Completed | 175 |
| Not completed | 27 |
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed.
| Participants | CyclASol Ophthalmic Solution |
|---|---|
| Number of Subjects Reporting Any Adverse Events | 97 |
Collected over Data were collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CyclASol Ophthalmic Solution | 0/200 (0%) | 4/200 (2%) | 13/200 (6.5%) |
| Event | CyclASol Ophthalmic Solution |
|---|---|
| PneumoniaInfections and infestations | 2/200 |
| Transient ischemic attachNervous system disorders | 1/200 |
| Cerebrovascular AccidentNervous system disorders | 1/200 |
| Atrial FibrillationCardiac disorders | 1/200 |
| CellulitisInfections and infestations | 1/200 |
| AnemiaBlood and lymphatic system disorders | 1/200 |
| Event | CyclASol Ophthalmic Solution |
|---|---|
| Instillation site painEye disorders | 13/200 |
202 participants were enrolled. Two participants were lost to follow-up directly after Visit 1. The safety population comprised 200 participants.
| Age, Continuous(years) | CyclASol Ophthalmic Solution |
|---|---|
| Mean | 59 ± 14.78 |
| Sex: Female, Male(Participants) | CyclASol Ophthalmic Solution |
|---|---|
| Female | 148 |
| Male | 52 |
| Ethnicity (NIH/OMB)(Participants) | CyclASol Ophthalmic Solution |
|---|---|
| Hispanic or Latino | 24 |
| Not Hispanic or Latino | 175 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | CyclASol Ophthalmic Solution |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 17 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 27 |
| White | 153 |
| More than one race | 2 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | CyclASol Ophthalmic Solution |
|---|---|
| United States | 200 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Apr 2022, 15 months.
Results were first posted in Oct 2023, 1 year 5 months after primary completion. A results delay was requested in Dec 2022.
Of 81 industry-sponsored phase 3 interventional studies under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's 15 months is above that.
Counting every sponsor, half of 96 studies reached it within 10 months; a quarter within 7 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Novaliq GmbH