Refractive ErrorsPAVESNCT04032457
PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
A study testing Phase A - olifilcon B with Tangible Coatings and Phase B - etafilcon A with Tangible Coatings in people with Refractive Errors, run by Vision Service Plan at 6 sites in United States.
Trial summary
The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel… Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Phase A - olifilcon B with Tangible Coatings and Phase B - etafilcon A with Tangible Coatings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Mar 2019to 2 Aug 2019
- 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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy full-time wearers of spherical daily disposable contact lenses
- Vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 DS and from -1.00 to -7.00 DS
- Visual acuity corrected to at least 20/30 with spherical contact lens
Who cannot join
- Participating in another clinical trial
- Vision not correctable to 20/30 with lens powers listed above
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Andover Optometry on Central
Andover, Massachusetts, 01810
Ross Eyecare
Atlanta, Georgia, 30324
Primary Eyecare Group, PC
Brentwood, Tennessee, 37027
RevolutionEyes
Carmel, Indiana, 46032
Professional Eye Care Center
Niles, Illinois, 60714
Professional VisionCare
Westerville, Ohio, 43081
About this study
The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
Read the detailed description
The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
- Conditions
- Refractive Errors
- Being tested
- Phase A - olifilcon B with Tangible Coatings, Phase B - etafilcon A with Tangible Coatings
- Keywords
- Contact Lens
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase A - olifilcon B with Tangible CoatingsDevice
Daily disposable silicone hydrogel contact lens
Phase B - etafilcon A with Tangible CoatingsDevice
Daily disposable hydrogel contact lens
| Study group | Role | What they receive |
|---|---|---|
| A1 - SiHyDD to Moist | Active comparator | 1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. Receives: Device: Phase A - olifilcon B with Tangible Coatings |
| A2 - Moist to SiHyDD | Active comparator | 1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. Receives: Device: Phase A - olifilcon B with Tangible Coatings |
| A3 - SiHyDD to OASDD | Active comparator | 1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses. Receives: Device: Phase A - olifilcon B with Tangible Coatings |
| A4 - OASDD to SiHyDD | Active comparator | 1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. Receives: Device: Phase A - olifilcon B with Tangible Coatings |
| A5 - SiHyDD to DT1 | Active comparator | 1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses. Receives: Device: Phase A - olifilcon B with Tangible Coatings |
| A6 - DT1 to SiHyDD | Active comparator | 1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. Receives: Device: Phase A - olifilcon B with Tangible Coatings |
| B1 - HydDD to Moist | Active comparator | 1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. Receives: Device: Phase B - etafilcon A with Tangible Coatings |
| B2 - Moist to HydDD | Active comparator | 1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses. Receives: Device: Phase B - etafilcon A with Tangible Coatings |
| B3 - HydDD to BioTrue | Active comparator | 1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses. Receives: Device: Phase B - etafilcon A with Tangible Coatings |
| B4 - BioTrue to HydDD | Active comparator | 1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses. Receives: Device: Phase B - etafilcon A with Tangible Coatings |
| B5 - HydDD to AqCom+ | Active comparator | 1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses. Receives: Device: Phase B - etafilcon A with Tangible Coatings |
| B6 - AqCom+ to HydDD | Active comparator | 1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses. Receives: Device: Phase B - etafilcon A with Tangible Coatings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Lens Preference
Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference.
Measured: Visit 3 - Approximately 2 weeks
Secondary outcomes (1)
8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score
Difference in CLDEQ-8 score with treatments relative to score with habitual lenses. The scale on the 8-item CLDEQ-8 instrument is from 1 to 33, with each item having a possible 4 or 5 points.
Measured: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start15 Mar 2019
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over after 1 week of wear of two lens brands.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vision Service Plan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foresight Regulatory Strategies, Inc.
- Responsible party
- Sponsor
- Investigators
- Robin L Chalmers, OD, Principal investigator, Clinical Trial Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032457
- Sponsor's protocol ID
- VS-19-01
- Acronym
- PAVES
- Status last verified
- Oct 2020
- First submitted
- 17 Apr 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT04032457
- Acronym / sponsor ID
- PAVES / VS-19-01
- Conditions
- Refractive Errors
- Keywords
- Contact Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Vision Service PlanIndustry (pharma, biotech, devices)
- Collaborators
- Foresight Regulatory Strategies, Inc.
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 25 Jul 2019 (actual)
- 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 study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
Detailed description
The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 12
- Model description
- Randomized cross-over after 1 week of wear of two lens brands.
| Arm | Type | Receives |
|---|---|---|
| A1 - SiHyDD to Moist | Active comparator | Device: Phase A - olifilcon B with Tangible Coatings1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. |
| A2 - Moist to SiHyDD | Active comparator | Device: Phase A - olifilcon B with Tangible Coatings1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. |
| A3 - SiHyDD to OASDD | Active comparator | Device: Phase A - olifilcon B with Tangible Coatings1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses. |
| A4 - OASDD to SiHyDD | Active comparator | Device: Phase A - olifilcon B with Tangible Coatings1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. |
| A5 - SiHyDD to DT1 | Active comparator | Device: Phase A - olifilcon B with Tangible Coatings1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses. |
| A6 - DT1 to SiHyDD | Active comparator | Device: Phase A - olifilcon B with Tangible Coatings1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. |
| B1 - HydDD to Moist | Active comparator | Device: Phase B - etafilcon A with Tangible Coatings1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. |
| B2 - Moist to HydDD | Active comparator | Device: Phase B - etafilcon A with Tangible Coatings1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses. |
| B3 - HydDD to BioTrue | Active comparator | Device: Phase B - etafilcon A with Tangible Coatings1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses. |
| B4 - BioTrue to HydDD | Active comparator | Device: Phase B - etafilcon A with Tangible Coatings1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses. |
| B5 - HydDD to AqCom+ | Active comparator | Device: Phase B - etafilcon A with Tangible Coatings1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses. |
| B6 - AqCom+ to HydDD | Active comparator | Device: Phase B - etafilcon A with Tangible Coatings1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy full-time wearers of spherical daily disposable contact lenses
- Vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 DS and from -1.00 to -7.00 DS
- Visual acuity corrected to at least 20/30 with spherical contact lens
Key exclusion criteria (2 listed)
- Participating in another clinical trial
- Vision not correctable to 20/30 with lens powers listed above
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 |
|---|---|---|
| Phase A - olifilcon B with Tangible CoatingsDaily disposable silicone hydrogel contact lens | Device | A1 - SiHyDD to Moist, A2 - Moist to SiHyDD, A3 - SiHyDD to OASDD, A4 - OASDD to SiHyDD, A5 - SiHyDD to DT1, A6 - DT1 to SiHyDD |
| Phase B - etafilcon A with Tangible CoatingsDaily disposable hydrogel contact lens | Device | B1 - HydDD to Moist, B2 - Moist to HydDD, B3 - HydDD to BioTrue, B4 - BioTrue to HydDD, B5 - HydDD to AqCom+, B6 - AqCom+ to HydDD |
Primary outcome
Subjective Lens Preference
Time frame: Visit 3 - Approximately 2 weeks
Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference.
1 secondary outcome
8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score
Time frame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
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 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Robin L Chalmers, OD principal investigator
Clinical Trial Consultant
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase A - olifilcon B with Tangible Coatings and Phase B - etafilcon A with Tangible Coatings in people with Refractive Errors, run by Vision Service Plan at 6 sites 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 3 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Subjective Lens Preference (time frame: Visit 3 - Approximately 2 weeks). 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 Oct 2020.