Dry Eye SyndromesPhase 2NCT02617667

CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

A Phase 2 study testing Cyclosporine A in people with Dry Eye Syndromes, run by Novaliq GmbH at 4 sites in United States.

Completed

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

Official record

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Trial summary

The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED). Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Dry Eye Syndromes
What is being tested?: Cyclosporine A
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: 4 sitesUnited States
Study dates: Jan 2016to Sep 2016
Phase: Phase 2
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document
Patient-reported history of dry eye in both eyes
Current use of over-the-counter and/or prescription eye drops for dry eye symptoms
Ability and willingness to follow instructions, including participation in all study assessments and visits

Who cannot join

Women who are pregnant, nursing or planning a pregnancy
Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
Clinically significant slit-lamp findings or abnormal lid anatomy at screening
DED secondary to scarring or ocular or periocular malignancy
History of herpetic keratitis
Active ocular allergies or ocular allergies that are expected to be active during the study period

Show all 12Show fewer

Ongoing ocular or systemic infection at screening or baseline
Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening
Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
Presence of an uncontrolled systemic disease
Presence of a known allergy and/or sensitivity to the study drug or its components

Trial locations and contacts

4 sites in 1 country.

United States4 sites

CYS-002 Investigational Site
Andover, Massachusetts, 01810
CYS-002 Investigational Site
Lewiston, Maine, 04240
CYS-002 Investigational Site
Newport Beach, California, 92663
CYS-002 Investigational Site
Quincy, Massachusetts, 02169

Other trials in United States

About this study

Official title: A Phase 2, Multi-center, Randomized, Double-masked, Placebo (Vehicle)-Controlled Clinical Study With an Open Label Comparator Arm to Assess the Efficacy, Safety and Tolerability of Topical CyclASol® for Treatment of Dry Eye Disease

Read the detailed description

This phase 2 study explored the safety, efficacy and tolerability of two CyclASol concentrations as one drop twice daily versus vehicle (placebo). In addition to the masked vehicle control arm, an open-label comparator arm consisting of Restasis was included.

The study explored a range of signs and symptoms of DED to gain an understanding of the possible treatment effects in comparison to vehicle and estimation of effect sizes. In line with current treatment guidelines, the proposed phase 2 population consisted of patients suffering from moderate to severe DED.

The primary treatment comparisons in this study were between the two CyclASol concentrations versus vehicle for the sign variable total corneal fluorescein staining and the symptom variable dryness severity visual analogue scale at day 113. All other comparisons between treatments groups were considered secondary analyses.

Conditions: Dry Eye Syndromes
Being tested: Cyclosporine A, Placebo
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 ADrug
Also called Ciclosporin, CsA
topical ocular, eye drops
PlaceboDrug
Also called Excipient
topical ocular, eye drops

Study groups in NCT02617667
Study group	Role	What they receive
CyclASol Ophthalmic Solution 1	Experimental	Cyclosporine A solution (dose-level 1) in vehicle Receives: Drug: Cyclosporine A
CyclASol Ophthalmic Solution 2	Experimental	Cyclosporine A solution (dose-level 2) in vehicle Receives: Drug: Cyclosporine A
Placebo Ophthalmic Solution	Placebo comparator	Vehicle only Receives: Drug: Placebo
Restasis	Active comparator	Cyclosporine A 0.05% ophthalmic emulsion Receives: Drug: Cyclosporine A

What is being measured

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

Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days
The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.
Measured: Baseline to 113 Days
Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days
The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to "no dryness" and 100% corresponds to "maximum dryness".
Measured: Baseline to 113 Days

Timeline

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

Jan 2016Sep 2016

First posted1 Dec 2015 (estimated)
Study startJan 2016
Primary completionJul 2016
Study completionSep 2016

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 SyndromesStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02617667
Sponsor's protocol ID: CYS-002
Status last verified: Oct 2019
First submitted: 25 Nov 2015
Last updated: 6 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Wirta DL, Torkildsen GL, Moreira HR, Lonsdale JD, Ciolino JB, Jentsch G, Beckert M, Ousler GW, Steven P, Krosser S. A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease. Ophthalmology. 2019 Jun;126(6):792-800. doi: 10.1016/j.ophtha.2019.01.024. Epub 2019 Jan 28.
PubMed 30703441

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?

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multi-center, Randomized, Double-masked, Placebo (Vehicle)-Controlled Clinical Study With an Open Label Comparator Arm to Assess the Efficacy, Safety and Tolerability of Topical CyclASol® for Treatment of Dry Eye Disease
ClinicalTrials.gov ID: NCT02617667
Acronym / sponsor ID: CYS-002
Conditions: Dry Eye Syndromes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Novaliq GmbHIndustry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Jul 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 1 Dec 2015 (estimated)
Results: Posted 26 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
CyclASol Ophthalmic Solution 1	Experimental	Drug: Cyclosporine ACyclosporine A solution (dose-level 1) in vehicle
CyclASol Ophthalmic Solution 2	Experimental	Drug: Cyclosporine ACyclosporine A solution (dose-level 2) in vehicle
Placebo Ophthalmic Solution	Placebo comparator	Drug: PlaceboVehicle only
Restasis	Active comparator	Drug: Cyclosporine ACyclosporine A 0.05% ophthalmic emulsion

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document
Patient-reported history of dry eye in both eyes
Current use of over-the-counter and/or prescription eye drops for dry eye symptoms
Ability and willingness to follow instructions, including participation in all study assessments and visits

Key exclusion criteria (12 listed)

Women who are pregnant, nursing or planning a pregnancy
Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
Clinically significant slit-lamp findings or abnormal lid anatomy at screening
DED secondary to scarring or ocular or periocular malignancy
History of herpetic keratitis

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 AAlso: Ciclosporin, CsAtopical ocular, eye drops	Drug	CyclASol Ophthalmic Solution 1, CyclASol Ophthalmic Solution 2, Restasis
PlaceboAlso: Excipienttopical ocular, eye drops	Drug	Placebo Ophthalmic Solution

Primary outcome

Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days
Time frame: Baseline to 113 Days
The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.
Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days
Time frame: Baseline to 113 Days
The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to "no dryness" and 100% corresponds to "maximum dryness".

Results and safety

Results posted to the registry on 26 Jul 2018, 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 0.05% Ophthalmic Solution	51	50
CyclASol 0.1% Ophthalmic Solution	51	50
Placebo Ophthalmic Solution	52	48
Restasis	53	52

Primary outcome: Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days

Time frame: Baseline to 113 Days. Mean (Standard Deviation). Unit: units on a scale

Measure	CyclASol 0.05% Ophthalmic Solution n = 51	CyclASol 0.1% Ophthalmic Solution n = 51	Placebo Ophthalmic Solution n = 52
Value	-2.38 (2.156)	-2.10 (2.252)	-1.69 (2.619)

Population analysed: Full analysis set population for worst eye. Worst eye: Eyes were eligible for analysis if they met all inclusion criteria. If both eyes qualified, the worst eye was taken as the eye with higher (worse) staining at Visit 1. If staining was the same, the right eye was selected as the worst eye.

Primary outcome: Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days

Time frame: Baseline to 113 Days. Mean (Standard Deviation). Unit: units on a scale

Measure	CyclASol 0.05% Ophthalmic Solution n = 51	CyclASol 0.1% Ophthalmic Solution n = 51	Placebo Ophthalmic Solution n = 52
Value	-11.00 (19.362)	-9.30 (27.832)	-13.85 (25.301)

Adverse events

Time frame: Adverse events reported were documented from the first dose of randomized study drug until the end of the last study day visit (day 113). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CyclASol 0.05% Ophthalmic Solution	2 of 51 (3.9%)	5 of 51 (9.8%)	0 of 51
CyclASol 0.1% Ophthalmic Solution	0 of 51 (0%)	4 of 51 (7.8%)	0 of 51
Placebo Ophthalmic Solution	0 of 52 (0%)	4 of 52 (7.7%)	0 of 52
Restasis	1 of 53 (1.9%)	4 of 53 (7.5%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30703441Wirta DL, Torkildsen GL, Moreira HR, Lonsdale JD, Ciolino JB, Jentsch G, Beckert M, Ousler GW, Steven P, Krosser S. A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease. Ophthalmology. 2019 Jun;126(6):792-800. doi: 10.1016/j.ophtha.2019.01.024. Epub 2019 Jan 28.
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 Kroesser, Dr.sc.hum. study director

Novaliq GmbH

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclosporine A in people with Dry Eye Syndromes, run by Novaliq GmbH at 4 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Jul 2018). 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 (Visit 1) in Total Corneal Fluorescein Staining at 113 Days (time frame: Baseline to 113 Days). The study lists 2 primary outcomes in all. 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 NCT02617667, 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 6 Nov 2019.