HealthyPhase 1NCT02113293
CyclASol® Phase 1 Study
A Phase 1 study testing CyclASol® in people with Healthy, run by Novaliq GmbH at 1 site in Germany.
Trial summary
This study is intended to investigate the tolerability and the safety of Cyclosporine A containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CyclASol®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subject aged 18 - 45 years
- Nonsmoker, for at least three months prior to first dose of trial medication
- BMI from 18.5 to 29.9 (kg/m2)
- Corneal/Conjunctival staining Oxford grading = 0°
- Schirmer I more than 10 mm/5min
- Tear Film Break-Up Time (TFBUT) equal or more than 10 s
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- Intra-ocular pressure between 10 and 20 mmHg
- Normal funduscopy
- Subject will have given their voluntary written informed consent to participate in the study in their own language and are willing to comply with the protocol
Who cannot join
- History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing)
- History of dry eye disease, ocular surgery, corneal disease
- Known hypersensitivity to the drug substance
- Limbal stem cell deficiency
- Cicatricial pemphigoid
- Glaucoma or known steroid response on intraocular pressure
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- Ocular allergy or incompatibility against Ciclosporin or semifluorinated alkanes
- Punctual occlusion
- Corrected vision with glasses less than 0.7 on one or both eyes
- Contact lens wear 3 weeks before to the planned first drug administration and/or during the study
- Acute infection of ocular surface (bacterial, viral, fungal...)
- Acute trauma of ocular surface
- No acceptable methods of birth control
- Pregnancy or breast-feeding period (females only)
- Use of any drugs whatsoever (including vitamins and herbals) for fourteen (14) days prior to the planned first drug administration (excluding contraceptives in women and single use of paracetamol or ibuprofen)
- Topical or systemic therapy with steroids, Ciclosporin, non-steroidal anti- inflammatory drugs, tetracyclines or other immunomodulatory substances within last 90 days prior to the planned first drug administration or during this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Two Period, Double-blind, Randomised, Placebo-controlled, Cross- Over Study Investigating the Safety, Local Tolerability and Systemic Exposure of Cyclosporine A and Placebo (Vehicle) Following Single and Multiple Ocular Doses of CyclASol® and Placebo in Healthy Volunteers (CYS-001).
This study is intended to investigate the tolerability and the safety of Cyclosporine A containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy volunteers. Subjects will be randomly assigned to dosing with CyclASol® eye drops or Placebo (vehicle) in the first part (first period) of the study, and switched to the alternative dosing in the second part (second period) of the study. An ophthalmological assessment of the eyes will be performed, and a questionnaire will be issued in the beginning and after each dosing. Additionally physical examinations, safety laboratory and ECGs will be performed, and blood samples will be analyzed for Cyclosporine A and Placebo (vehicle).
- Conditions
- Healthy
- Being tested
- CyclASol®, Placebo (vehicle)
- Keywords
- phase I study, tolerability, safety, CyclASol®, eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclASol®Drug
Cyclosporine A Solution
Placebo (vehicle)Drug
Vehicle Solution
| Study group | Role | What they receive |
|---|---|---|
| CyclASol® | Experimental | CyclASol® Receives: Drug: CyclASol® |
| Placebo | Placebo comparator | Placebo (vehicle) Receives: Drug: Placebo (vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tolerability measured by the rate and severity of drug-related adverse events of the eyes
Multiple ophthalmologic assessments are performed in order to determine adverse effects of the investigational medicinal product on structures of the eye and its physiology.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novaliq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Beckert, MD, Study director, Novaliq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113293
- Sponsor's protocol ID
- CYS-001
- Other IDs
- 2013-005423-16
- Status last verified
- May 2014
- First submitted
- 7 Apr 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two Period, Double-blind, Randomised, Placebo-controlled, Cross- Over Study Investigating the Safety, Local Tolerability and Systemic Exposure of Cyclosporine A and Placebo (Vehicle) Following Single and Multiple Ocular Doses of CyclASol® and Placebo in Healthy Volunteers (CYS-001).
- ClinicalTrials.gov ID
- NCT02113293
- Acronym / sponsor ID
- CYS-001
- Conditions
- Healthy
- Keywords
- phase I study, tolerability, safety, CyclASol®, eye drops
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novaliq GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to investigate the tolerability and the safety of Cyclosporine A containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy volunteers. Subjects will be randomly assigned to dosing with CyclASol® eye drops or Placebo (vehicle) in the first part (first period) of the study, and switched to the alternative dosing in the second part (second period) of the study. An ophthalmological assessment of the eyes will be performed, and a questionnaire will be issued in the beginning and after each dosing. Additionally physical examinations, safety laboratory and ECGs will be performed, and blood samples will be analyzed for Cyclosporine A and Placebo (vehicle).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CyclASol® | Experimental | Drug: CyclASol®CyclASol® |
| Placebo | Placebo comparator | Drug: Placebo (vehicle)Placebo (vehicle) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female subject aged 18 - 45 years
- Nonsmoker, for at least three months prior to first dose of trial medication
- BMI from 18.5 to 29.9 (kg/m2)
- Corneal/Conjunctival staining Oxford grading = 0°
- Schirmer I more than 10 mm/5min
Key exclusion criteria (16 listed)
- History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing)
- History of dry eye disease, ocular surgery, corneal disease
- Known hypersensitivity to the drug substance
- Limbal stem cell deficiency
- Cicatricial pemphigoid
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®Cyclosporine A Solution | Drug | CyclASol® |
| Placebo (vehicle)Vehicle Solution | Drug | Placebo |
Primary outcome
Local tolerability measured by the rate and severity of drug-related adverse events of the eyes
Time frame: 45 days
Multiple ophthalmologic assessments are performed in order to determine adverse effects of the investigational medicinal product on structures of the eye and its physiology.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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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.
Michael Beckert, MD study director
Novaliq GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CyclASol® in people with Healthy, run by Novaliq GmbH at 1 site in Germany.
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 9 inclusion and 16 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Local tolerability measured by the rate and severity of drug-related adverse events of the eyes (time frame: 45 days). 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 20 May 2014.