Dry Eye SyndromePhase 1NCT01747616
Assessment of Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Subjects While Wearing Contact Lenses and Before Insertion of Contact Lenses
A Phase 1 study testing Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) and Physiological saline solution in people with Dry Eye Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no "ideal" formulation has yet been found. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) and Physiological saline solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2011to Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Regular contact lens wear since 3 years minimum
- Daily wearing time of the contact lens of 8 hours or more
- Good tolerability of the contact lenses without ocular discomfort or local signs of chemosis, conjunctival redness or other signs of intolerability as judged by the investigator.
- Subject willing to continue contact lens use for the study period
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings except ametropia
Who cannot join
- Participation in a clinical trial in the 3 weeks preceding the study
- Use of colored contact lenses
- Abuse of alcoholic beverages or other drugs
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no "ideal" formulation has yet been found.
Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. Additionally, the new formulation comprises N-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. Based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with DES. We have recently shown in a phase I trial that single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy subjects.
However, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine in subjects wearing contact lenses. This is of special interest because the tear film is critical to successful contact lens wear. Disturbances of the quantity or quality of the tear film results in intolerance of contact lens wear and possible damage to the ocular surface. This trial seeks to investigate the local tolerability and possible ocular discomfort of chitosan-N-acetylcysteine eye drops after repeated instillation .
- Conditions
- Dry Eye Syndrome
- Being tested
- Chitosan-N-acetylcysteine eye drops (concentration of 0.1%), Physiological saline solution
- Keywords
- Chitosan-N-Acetylcysteine, contact lenses, safety and tolerability
- 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.
Chitosan-N-acetylcysteine eye drops (concentration of 0.1%)Device
1 drop of the medical device in 1 randomly chosen eye
Physiological saline solutionOther
1 drop as placebo in the other eye not receiving the medical device
| Study group | Role | What they receive |
|---|---|---|
| 12 subjects wearing soft contact lenses | Experimental | The medical test device will be administered with the contact lenses inserted Receives: Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution |
| 12 subjects wearing rigid contact lenses | Experimental | The medical test device will be administered with the contact lenses inserted Receives: Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution |
| 12 subjects with soft contact lenses | Experimental | The medical test device will be administered before insertion of the contact lenses Receives: Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution |
| 12 subjects with rigid contact lenses | Experimental | The medical test device will be administered before insertion of the contact lenses Receives: Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive evaluation of ocular discomfort as assessed by the subjects
Measured: on 5 consecutive days before and after instillation of the eye drops
Secondary outcomes (2)
Number of subjects with significant increase of redness
Measured: on 5 consecutive study days
Number of subjects experiencing adverse reactions
Measured: on 5 consecutive study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Croma-Pharma GmbH
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747616
- Sponsor's protocol ID
- OPHT-290311
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Subjects While Wearing Contact Lenses and Before Insertion of Contact Lenses
- ClinicalTrials.gov ID
- NCT01747616
- Acronym / sponsor ID
- OPHT-290311
- Conditions
- Dry Eye Syndrome
- Keywords
- Chitosan-N-Acetylcysteine, contact lenses, safety and tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Croma-Pharma GmbH
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Dec 2012 (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.
The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no "ideal" formulation has yet been found.
Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. Additionally, the new formulation comprises N-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. Based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with DES. We have recently shown in a phase I trial that single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy subjects.
However, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine in subjects wearing contact lenses. This is of special interest because the tear film is critical to successful contact lens wear. Disturbances of the quantity or quality of the tear film results in intolerance of contact lens wear and possible damage to the ocular surface. This trial seeks to investigate the local tolerability and possible ocular discomfort of chitosan-N-acetylcysteine eye drops after repeated instillation .
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 |
|---|---|---|
| 12 subjects wearing soft contact lenses | Experimental | Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%), Other: Physiological saline solutionThe medical test device will be administered with the contact lenses inserted |
| 12 subjects wearing rigid contact lenses | Experimental | Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%), Other: Physiological saline solutionThe medical test device will be administered with the contact lenses inserted |
| 12 subjects with soft contact lenses | Experimental | Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%), Other: Physiological saline solutionThe medical test device will be administered before insertion of the contact lenses |
| 12 subjects with rigid contact lenses | Experimental | Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%), Other: Physiological saline solutionThe medical test device will be administered before insertion of the contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Regular contact lens wear since 3 years minimum
- Daily wearing time of the contact lens of 8 hours or more
- Good tolerability of the contact lenses without ocular discomfort or local signs of chemosis, conjunctival redness or other signs of intolerability as judged by the investigator.
- Subject willing to continue contact lens use for the study period
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (5 listed)
- Participation in a clinical trial in the 3 weeks preceding the study
- Use of colored contact lenses
- Abuse of alcoholic beverages or other drugs
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Pregnancy
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 |
|---|---|---|
| Chitosan-N-acetylcysteine eye drops (concentration of 0.1%)1 drop of the medical device in 1 randomly chosen eye | Device | 12 subjects wearing rigid contact lenses, 12 subjects wearing soft contact lenses, 12 subjects with rigid contact lenses, 12 subjects with soft contact lenses |
| Physiological saline solution1 drop as placebo in the other eye not receiving the medical device | Other | 12 subjects wearing rigid contact lenses, 12 subjects wearing soft contact lenses, 12 subjects with rigid contact lenses, 12 subjects with soft contact lenses |
Primary outcome
Descriptive evaluation of ocular discomfort as assessed by the subjects
Time frame: on 5 consecutive days before and after instillation of the eye drops
2 secondary outcomes
Number of subjects with significant increase of redness
Time frame: on 5 consecutive study days
Number of subjects experiencing adverse reactions
Time frame: on 5 consecutive study days
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 11 Dec 2012.
Related trials for Dry Eye Syndrome
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) and Physiological saline solution in people with Dry Eye Syndrome, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 5 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 11 Dec 2012. 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 Austria. 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 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?
Descriptive evaluation of ocular discomfort as assessed by the subjects (time frame: on 5 consecutive days before and after instillation of the eye drops). 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 11 Dec 2012.