Contact Lens CareNCT00885092
Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution
A study testing FID 114675A Multi-Purpose Disinfecting Solution (MPDS), RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®) 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 an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses. 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), RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®) 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
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to May 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.
- Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).
- Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).
- Other protocol-defined 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 screening or 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: Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution
The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.
- Conditions
- Contact Lens Care
- Being tested
- FID 114675A Multi-Purpose Disinfecting Solution (MPDS), RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®), Senofilcon A contact lens (ACUVUE® Oasys™), 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.
RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)Device
Also called (OPTI-FREE® RepleniSH®)
Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.
Senofilcon A contact lens (ACUVUE® Oasys™)Device
Also called ACUVUE® Oasys™
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 / RepleniSH | Other | FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis. Receives: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®); Device: Senofilcon A contact lens (ACUVUE® Oasys™); Device: Balafilcon A contact lens (PureVision®) |
| RepleniSH / FID 114675A | Other | RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis. Receives: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®); Device: Senofilcon A contact lens (ACUVUE® Oasys™); Device: Balafilcon A contact lens (PureVision®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Ex-Vivo Wetting Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Measured: Day 7, Hour 14
Secondary outcomes (2)
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, "My lenses feel comfortable right now," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.
Measured: Day 7, Hour 14
Percentage of Participants With 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 and is reported as a percentage of total participants.
Measured: Day 7, Hour 14
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 completionMay 2009
- Study completionMay 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT00885092
- Sponsor's protocol ID
- C-08-082
- 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
- Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution
- ClinicalTrials.gov ID
- NCT00885092
- Acronym / sponsor ID
- C-08-082
- Conditions
- Contact Lens Care
- Keywords
- Contact lenses, Disinfecting solutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Posted 20 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 an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID 114675A / RepleniSH | Other | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®), Device: Senofilcon A contact lens (ACUVUE® Oasys™), Device: Balafilcon A contact lens (PureVision®)FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis. |
| RepleniSH / FID 114675A | Other | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS), Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®), Device: Senofilcon A contact lens (ACUVUE® Oasys™), Device: Balafilcon A contact lens (PureVision®)RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis. |
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.
- Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).
- Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).
- Other protocol-defined 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 / RepleniSH, RepleniSH / FID 114675A |
| RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)Also: (OPTI-FREE® RepleniSH®)Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses. | Device | FID 114675A / RepleniSH, RepleniSH / FID 114675A |
| Senofilcon A contact lens (ACUVUE® Oasys™)Also: ACUVUE® Oasys™Commercially marketed silicone hydrogel contact lens for daily wear use | Device | FID 114675A / RepleniSH, RepleniSH / FID 114675A |
| Balafilcon A contact lens (PureVision®)Also: PureVision®Commercially marketed silicone hydrogel contact lens for daily wear use | Device | FID 114675A / RepleniSH, RepleniSH / FID 114675A |
Primary outcome
Mean Ex-Vivo Wetting Angle
Time frame: Day 7, Hour 14
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
2 secondary outcomes
Mean Lens Comfort
Time frame: Day 7, Hour 14
Percentage of Participants With Solution-Related Corneal Staining
Time frame: Day 7, Hour 14
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), RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®) 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 20 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?
Mean Ex-Vivo Wetting Angle (time frame: Day 7, Hour 14). 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.