Contact Lens CareNCT00884806
7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers
A study testing FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Etafilcon A contact lens (ACUVUE® 2™) and Senofilcon A contact lens (ACUVUE® OASYS™) in people with Contact Lens Care, run by Alcon Research.
Trial summary
The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Care
- What is being tested?
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Etafilcon A contact lens (ACUVUE® 2™) and Senofilcon A contact lens (ACUVUE® OASYS™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jun 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit).
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1.
- Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit).
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
- Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
- Monocular vision (only one eye with functional vision) or fit with only one contact lens.
- Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
- Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
- Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
Show all 11Show fewer
- Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
- Corneal staining area assessment ≥ 20% in any corneal region in either eye at baseline visit.
- Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
- Participation in any investigational clinical study within 30 days of baseline visit.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Corneal Staining Evaluation of SiH MPDS FID 114675A
The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.
- Conditions
- Contact Lens Care
- Being tested
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Etafilcon A contact lens (ACUVUE® 2™), Senofilcon A contact lens (ACUVUE® OASYS™), Lotrafilcon B contact lens (O2 OPTIX®), Balafilcon A contact lens (PureVision®)
- Keywords
- Contact lenses, Disinfecting solutions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID 114675A Multi-Purpose Disinfecting Solution (MPDS)Device
Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses
Etafilcon A contact lens (ACUVUE® 2™)Device
Also called ACUVUE® 2™
Commercially marketed hydrogel contact lens for daily wear use
Senofilcon A contact lens (ACUVUE® OASYS™)Device
Also called ACUVUE® OASYS™
Commercially marketed silicone hydrogel contact lens for daily wear use
Lotrafilcon B contact lens (O2 OPTIX®)Device
Also called O2 OPTIX®
Commercially marketed silicone hydrogel contact lens for daily wear use
Balafilcon A contact lens (PureVision®)Device
Also called PureVision®
Commercially marketed silicone hydrogel contact lens for daily wear use
| Study group | Role | What they receive |
|---|---|---|
| FID 114675A | Experimental | FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only. Receives: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Etafilcon A contact lens (ACUVUE® 2™); Device: Senofilcon A contact lens (ACUVUE® OASYS™); Device: Lotrafilcon B contact lens (O2 OPTIX®); Device: Balafilcon A contact lens (PureVision®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solution-Related Corneal Staining
Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.
Measured: Day 7
Secondary outcomes (1)
Mean Lens Comfort
Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "Over the previous 2-3 hours, my lenses felt comfortable," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
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.
- Other trials for Contact Lens CareStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT00884806
- Sponsor's protocol ID
- C-08-081
- Status last verified
- Mar 2012
- First submitted
- 17 Apr 2009
- Last updated
- 27 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Staining Evaluation of SiH MPDS FID 114675A
- ClinicalTrials.gov ID
- NCT00884806
- Acronym / sponsor ID
- C-08-081
- Conditions
- Contact Lens Care
- Keywords
- Contact lenses, Disinfecting solutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Posted 22 Mar 2012
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 this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FID 114675A | Experimental | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Device: Etafilcon A contact lens (ACUVUE® 2™), Device: Senofilcon A contact lens (ACUVUE® OASYS™), Device: Lotrafilcon B contact lens (O2 OPTIX®), Device: Balafilcon A contact lens (PureVision®)FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit).
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1.
- Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit).
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (11 listed)
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
- Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
- Monocular vision (only one eye with functional vision) or fit with only one contact lens.
- Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
- Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
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 |
|---|---|---|
| FID 114675A Multi-Purpose Disinfecting Solution (MPDS)Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses | Device | FID 114675A |
| Etafilcon A contact lens (ACUVUE® 2™)Also: ACUVUE® 2™Commercially marketed hydrogel contact lens for daily wear use | Device | FID 114675A |
| Senofilcon A contact lens (ACUVUE® OASYS™)Also: ACUVUE® OASYS™Commercially marketed silicone hydrogel contact lens for daily wear use | Device | FID 114675A |
| Lotrafilcon B contact lens (O2 OPTIX®)Also: O2 OPTIX®Commercially marketed silicone hydrogel contact lens for daily wear use | Device | FID 114675A |
| Balafilcon A contact lens (PureVision®)Also: PureVision®Commercially marketed silicone hydrogel contact lens for daily wear use | Device | FID 114675A |
Primary outcome
Solution-Related Corneal Staining
Time frame: Day 7
Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.
1 secondary outcome
Mean Lens Comfort
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Etafilcon A contact lens (ACUVUE® 2™) and Senofilcon A contact lens (ACUVUE® OASYS™) in people with Contact Lens Care, run by Alcon Research.
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 5 inclusion and 11 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 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Mar 2012). 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?
Solution-Related Corneal Staining (time frame: Day 7). 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 27 Mar 2012.