VisionNCT00713076
Wettability of Contact Lenses With a Multi-Purpose Solution
A study testing Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182 in people with Vision, run by Alcon Research at 1 site in United States.
Trial summary
Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a Multi-Purpose Solution. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision
- What is being tested?
- Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with normal eyes who have successfully worn contact lenses on a daily basis for at least two weeks prior to the study.
- Must be wearing lenses a minimum of eight hours a day
- Vision must be correctable to 20/30 (snellen) or better in each eye at a distance with soft contact lenses
- Use no topical ocular OTC or prescribed ocular medication
Who cannot join
- Subjects with current lid or conjunctival infections, abnormalities, inflammation, abnormal corneal opacities, significant lenticular inclusions, iritis, ocular disease or condition, corneal surgery, cataract surgery, intraocular lens implants, or glaucoma filtering surgery.
- Subjects using systemic medications, upper respiratory infections or colds, history of seasonal allergies with significant ocular side effects
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, 76134
About this study
Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a Multi-Purpose Solution.
- Conditions
- Vision
- Being tested
- Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182
- Keywords
- multi-purpose solution, contact lens wearers, Contact lense wearers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182Other
Lens Cleaning Solution Formulation Identification Number 109182
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Polyquaternium-preserved Multi-purpose solution Receives: Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Wettability - ex-vivo wetting angle
Measured: From baseline
Secondary outcomes (1)
Slit-lamp findings Corrected visual acuity (snellen) Adverse events
Measured: From baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VisionStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713076
- Sponsor's protocol ID
- C-07-18
- Status last verified
- Jul 2008
- First submitted
- 18 Jun 2008
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wettability of Contact Lenses With a Multi-Purpose Solution
- ClinicalTrials.gov ID
- NCT00713076
- Acronym / sponsor ID
- C-07-18
- Conditions
- Vision
- Keywords
- multi-purpose solution, contact lens wearers, Contact lense wearers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- First posted
- 11 Jul 2008 (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.
Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a Multi-Purpose Solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182Polyquaternium-preserved Multi-purpose solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with normal eyes who have successfully worn contact lenses on a daily basis for at least two weeks prior to the study.
- Must be wearing lenses a minimum of eight hours a day
- Vision must be correctable to 20/30 (snellen) or better in each eye at a distance with soft contact lenses
- Use no topical ocular OTC or prescribed ocular medication
Key exclusion criteria (2 listed)
- Subjects with current lid or conjunctival infections, abnormalities, inflammation, abnormal corneal opacities, significant lenticular inclusions, iritis, ocular disease or condition, corneal surgery, cataract surgery, intraocular lens implants, or glaucoma filtering surgery.
- Subjects using systemic medications, upper respiratory infections or colds, history of seasonal allergies with significant ocular side effects
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 |
|---|---|---|
| Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182Lens Cleaning Solution Formulation Identification Number 109182 | Other | 1 |
Primary outcome
Lens Wettability - ex-vivo wetting angle
Time frame: From baseline
1 secondary outcome
Slit-lamp findings Corrected visual acuity (snellen) Adverse events
Time frame: From baseline
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 Aug 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.
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 study testing Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182 in people with Vision, run by Alcon Research at 1 site 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 2 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 Aug 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 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.
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?
Lens Wettability - ex-vivo wetting angle (time frame: From baseline). 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 Aug 2014.