Adverse Reaction to Contact Lens SolutionNCT01665612
The Clinical and Subjective Performance of Three Different MPDS With Silicon Hydrogel Lenses
A study testing Contact lens care solution in people with Adverse Reaction to Contact Lens Solution, run by Finnsusp Ltd. at 1 site in Finland.
Trial summary
The purpose of the clinical investigation is to assess the clinical and subjective performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Reaction to Contact Lens Solution
- What is being tested?
- Contact lens care solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2012to Jan 2015
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age above 18
- experienced contact lens user
- good health (self-reported)
Who cannot join
- eye disease or eye operations
- pregnancy
- medication that can affect sight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of the Clinical and Subjective Performance of Three Different Contact Lens Care Solutions With Silicon Hydrogel Lenses
The purpose of the clinical investigation is to assess the clinical and subjective performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).
- Being tested
- Contact lens care solution
- Keywords
- Contact lens, Care solution, MPDS, comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact lens care solutionDevice
Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses
| Study group | Role | What they receive |
|---|---|---|
| MPDS1 | Experimental | Contact lens care solution Receives: Device: Contact lens care solution |
| MPDS2 | Active comparator | Contact lens care solution Receives: Device: Contact lens care solution |
| MPDS3 | Active comparator | Contact lens care solution Receives: Device: Contact lens care solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis
Measured: 1 month
Secondary outcomes (1)
Subjective performance
E.g. Comfort
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Reaction to Contact Lens SolutionStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnsusp Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Riikka Järvinen, PhD, Study director, University of Turku, Finland; Finnsusp Ltd, FinlandHanna Vaahtoranta-Lehtonen, Dr. Ophth., Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665612
- Sponsor's protocol ID
- FI-2012
- Status last verified
- Mar 2015
- First submitted
- 8 Aug 2012
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Clinical and Subjective Performance of Three Different Contact Lens Care Solutions With Silicon Hydrogel Lenses
- ClinicalTrials.gov ID
- NCT01665612
- Acronym / sponsor ID
- FI-2012
- Keywords
- Contact lens, Care solution, MPDS, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Finnsusp Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2015 (actual)
- First posted
- 15 Aug 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 purpose of the clinical investigation is to assess the clinical and subjective performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MPDS1 | Experimental | Device: Contact lens care solutionContact lens care solution |
| MPDS2 | Active comparator | Device: Contact lens care solutionContact lens care solution |
| MPDS3 | Active comparator | Device: Contact lens care solutionContact lens care solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age above 18
- experienced contact lens user
- good health (self-reported)
Key exclusion criteria (3 listed)
- eye disease or eye operations
- pregnancy
- medication that can affect sight
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 |
|---|---|---|
| Contact lens care solutionComparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses | Device | MPDS1, MPDS2, MPDS3 |
Primary outcome
Clinical performance
Time frame: 1 month
TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis
1 secondary outcome
Subjective performance
Time frame: 1 month
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 6 Mar 2015.
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.
Riikka Järvinen, PhD study director
University of Turku, Finland; Finnsusp Ltd, Finland
Hanna Vaahtoranta-Lehtonen, Dr. Ophth. principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact lens care solution in people with Adverse Reaction to Contact Lens Solution, run by Finnsusp Ltd. at 1 site in Finland.
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 3 inclusion and 3 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 Mar 2015. 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 Finland. 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.
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?
Clinical performance (time frame: 1 month). 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 6 Mar 2015.