Dry Eye Disease (DED)Phase 3NCT04523142

CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

A Phase 3 study testing CyclASol Ophthalmic Solution in people with Dry Eye Disease (DED), run by Novaliq GmbH at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Disease (DED)
What is being tested?: CyclASol Ophthalmic Solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: 14 sitesUnited States
Study dates: 4 Jan 2021to 23 May 2022
Phase: Phase 3
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

Have completed the clinical trial CYS-004 and habe been compliant with trial procedures
Signed ICF (Informed Consent Form)
Subject-reported history of DED in both eyes
Ability and willingness to follow instructions, including participation in all study assessments and visits

Who cannot join

Early termination of CYS-004
Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters
Have a history of herpetic keratitis;
Have an ocular or periocular malignancy;
Be unwilling to avoid wearing contact lenses during the trial;
Have any planned ocular or eyelid surgeries during the trial period

Show all 12Show fewer

Be a woman who is pregnant, nursing or planning a pregnancy
Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential
Women of childbearing potential not using an acceptable means of contraception
Presence of known allergy and/or sensitivity to the study drug or its components
Be currently using an investigational drug or device or have used an investigational drug or device within 60 days before Visit 1 other than for CYS-004
Have a condition or be in a situation (eg language barrier) 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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

CYS-005 Investigational Site
Andover, Massachusetts, 01810
CYS-005 Investigational Site
Carmel, Indiana, 46290
CYS-005 Investigational Site
Cranberry Township, Pennsylvania, 16066
CYS-005 Investigational Site
Fargo, North Dakota, 58103
CYS-005 Investigational Site
Henderson, Nevada, 89052
CYS-005 Investigational Site
Layton, Utah, 84041
CYS-005 Investigational Site
Los Angeles, California, 90013
CYS-005 Investigational Site
Louisville, Kentucky, 40206
CYS-005 Investigational Site
Lynchburg, Virginia, 24502
CYS-005 Investigational Site
Memphis, Tennessee, 38119
CYS-005 Investigational Site
Newport Beach, California, 92663
CYS-005 Investigational Site
Raleigh, North Carolina, 27603
CYS-005 Investigtional Site
Raynham, Massachusetts, 02767
CYS-005 Investigational Site
Shelby, North Carolina, 28150

Other trials in United States

About this study

Official title: A Phase 3, Multi-center, Open-label, Single-arm Clinical Trial to Assess the Long-term Safety and Tolerability of Topical CyclASol® for the Treatment of Dry Eye Disease in Subjects Who Completed the Clinical Trial CYS-004

The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.

Read the detailed description

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.

Conditions: Dry Eye Disease (DED)
Being tested: CyclASol Ophthalmic Solution
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.

CyclASol Ophthalmic SolutionDrug
Cyclosporine A solution in vehicle

Study groups in NCT04523142
Study group	Role	What they receive
CyclASol Ophthalmic Solution	Experimental	Cyclosporine A solution in vehicle Receives: Drug: CyclASol Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 202123 May 2022

First posted21 Aug 2020
Study start4 Jan 2021
Primary completion30 Apr 2022
Study completion23 May 2022

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry Eye Disease (DED)Studies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04523142
Sponsor's protocol ID: CYS-005
Status last verified: Aug 2023
First submitted: 19 Aug 2020
Last updated: 16 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Wirta DL, Galor A, Aune CA, Vollmer PM, Liang E, Meides AS, Krosser S. Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE. Cornea. 2024 May 21;44(6):692-700. doi: 10.1097/ICO.0000000000003567.
PubMed 38771801

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity

All Dry Eye Disease (DED) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-center, Open-label, Single-arm Clinical Trial to Assess the Long-term Safety and Tolerability of Topical CyclASol® for the Treatment of Dry Eye Disease in Subjects Who Completed the Clinical Trial CYS-004
ClinicalTrials.gov ID: NCT04523142
Acronym / sponsor ID: CYS-005
Conditions: Dry Eye Disease (DED)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Novaliq GmbHIndustry (pharma, biotech, devices)
Study start: 4 Jan 2021 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 23 May 2022 (actual)
First posted: 21 Aug 2020 (actual)
Results: Posted 16 Oct 2023

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 safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CyclASol Ophthalmic Solution	Experimental	Drug: CyclASol Ophthalmic SolutionCyclosporine A solution in vehicle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have completed the clinical trial CYS-004 and habe been compliant with trial procedures
Signed ICF (Informed Consent Form)
Subject-reported history of DED in both eyes
Ability and willingness to follow instructions, including participation in all study assessments and visits

Key exclusion criteria (12 listed)

Early termination of CYS-004
Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters
Have a history of herpetic keratitis;
Have an ocular or periocular malignancy;
Be unwilling to avoid wearing contact lenses during the trial;

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
CyclASol Ophthalmic SolutionCyclosporine A solution in vehicle	Drug	CyclASol Ophthalmic Solution

Primary outcome

Number of Subjects Reporting Any Adverse Events
Time frame: 12 months
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.

Results and safety

Results posted to the registry on 16 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CyclASol Ophthalmic Solution	202	175

Primary outcome: Number of Subjects Reporting Any Adverse Events

Time frame: 12 months. Count of participants. Unit: Participants

Measure	CyclASol Ophthalmic Solution n = 200
Value	97

Population analysed: Safety Analysis Set

Adverse events

Time frame: Data were collected over 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CyclASol Ophthalmic Solution	4 of 200 (2%)	13 of 200 (6.5%)	0 of 200

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38771801Wirta DL, Galor A, Aune CA, Vollmer PM, Liang E, Meides AS, Krosser S. Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE. Cornea. 2024 May 21;44(6):692-700. doi: 10.1097/ICO.0000000000003567.
Individual participant dataSharing planned: No

Related trials for Dry Eye Disease (DED)

Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity

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 Kroesser, PhD study director

Novaliq GmbH

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CyclASol Ophthalmic Solution in people with Dry Eye Disease (DED), run by Novaliq GmbH at 14 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 12 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Oct 2023). 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?

Number of Subjects Reporting Any Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523142, which also lists 1 linked publication.

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 16 Oct 2023.