AmetropiaNCT02436005
Dispensing Study for the Phenacite Project
A study testing Phenacite and comfilcon A in people with Ametropia, run by CooperVision, Inc. at 1 site in United States.
Trial summary
Dispensing Study for the Phenacite Project. The investigational test lens was not the final optical design and the study was not used for design validation. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Ametropia
- What is being tested?
- Phenacite and comfilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jul 2015
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Oculo-visual examination in the last two years
- Between 18 and 35 years of age and has full legal capacity to volunteer
- Has read and understood the informed consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
Show all 11Show fewer
- Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
- Has not worn lenses for at least 12 hours before the initial visit
- Has a subjective response at baseline, which indicates suitability for this study
- Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
- Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.
Who cannot join
- Has never worn contact lenses before
- Any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- Has any ocular pathology or anomaly that would affect the wearing of the lenses
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
Show all 13Show fewer
- Is aphakic
- Has anisometropia of >1.00
- Has undergone corneal refractive surgery
- Has strabismus
- Has any ocular amblyopia >= 1line of HC Visual Acuity
- Is participating in any other type of eye related clinical or research study
- Has participated in study CV-14-32.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, 47405
About this study
Dispensing Study for the Phenacite Project.
The investigational test lens was not the final optical design and the study was not used for design validation.
Read the detailed description
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
- Conditions
- Ametropia
- Being tested
- Phenacite, comfilcon A
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenaciteDevice
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
comfilcon ADevice
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
| Study group | Role | What they receive |
|---|---|---|
| Phenacite | Experimental | Subjects will be randomized to wear the Phenacite contact lenses binocularly. Receives: Device: Phenacite; Device: comfilcon A |
| comfilcon A | Active comparator | Subjects will be randomized to wear the comfilcon A contact lenses binocularly. Receives: Device: Phenacite; Device: comfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Ratings of Lens Comfort
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Measured: Baseline (after 15 minutes of lens dispense)
Subjective Ratings of Lens Comfort
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Measured: 2 Weeks
Over Refraction for Optimized Distance Acuity
Over Refraction for optimized distance acuity measured using logMAR
Measured: 2 weeks
Binocular Distance Visual Acuity - High Illumination High Contrast
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Measured: Baseline (after 5 minutes of lens dispense)
Binocular Distance Visual Acuity - High Illumination High Contrast
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Measured: 2 weeks
Binocular Distance Visual Acuity - Low Illumination High Contrast
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Measured: Baseline (after 5 minutes of lens dispense)
Binocular Distance Visual Acuity - Low Illumination High Contrast
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Measured: 2 weeks
Binocular Near Visual Acuity - High Illumination High Contrast
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Measured: Baseline (after 5 minutes of lens dispense)
Binocular Near Visual Acuity - High Illumination High Contrast
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Measured: 2 weeks
Binocular Near Visual Acuity - Low Illumination High Contrast
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Measured: Baseline (after 5 minutes of lens dispense)
Binocular Near Visual Acuity - Low Illumination High Contrast
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Measured: 2 weeks
Secondary outcomes (18)
Lens Fit - Post Blink Movement
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Measured: Baseline (after 15 minutes of lens dispense)
Lens Fit - Post Blink Movement
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Measured: 2 weeks
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Measured: Baseline (after 15 minutes of lens dispense)
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Measured: 2 weeks
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Measured: Baseline (after 15 minutes of lens dispense)
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Measured: 2 weeks
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Measured: Baseline (after 15 minutes of lens dispense)
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Measured: 2 weeks
Subjective Ratings for Vision Quality - Distance Vision
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Measured: Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Distance Vision
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Measured: 2 weeks
Subjective Ratings for Vision Quality - Near Vision
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Measured: Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Near Vision
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Measured: 2 weeks
Subjective Ratings for Vision Quality - Computer Vision
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Measured: Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Computer Vision
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Measured: 2 weeks
Subjective Ratings for Vision Quality - Overall Vision
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Measured: Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Overall Vision
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Measured: 2 weeks
Corneal Staining Extent
Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- >45% of area
Measured: 2 weeks
Conjunctival Staining
Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionJul 2015
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 AmetropiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pete Kollbaun, OD PhD, Principal investigator, CORL Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436005
- Sponsor's protocol ID
- CV-15-16
- Status last verified
- Oct 2020
- First submitted
- 1 May 2015
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispensing Study for the Phenacite Project
- ClinicalTrials.gov ID
- NCT02436005
- Acronym / sponsor ID
- CV-15-16
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dispensing Study for the Phenacite Project.
The investigational test lens was not the final optical design and the study was not used for design validation.
Detailed description
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenacite | Experimental | Device: Phenacite, Device: comfilcon ASubjects will be randomized to wear the Phenacite contact lenses binocularly. |
| comfilcon A | Active comparator | Device: Phenacite, Device: comfilcon ASubjects will be randomized to wear the comfilcon A contact lenses binocularly. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Oculo-visual examination in the last two years
- Between 18 and 35 years of age and has full legal capacity to volunteer
- Has read and understood the informed consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
Key exclusion criteria (13 listed)
- Has never worn contact lenses before
- Any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- Has any ocular pathology or anomaly that would affect the wearing of the lenses
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 |
|---|---|---|
| PhenaciteSubjects will be randomized to wear the Phenacite contact lenses binocularly. | Device | Phenacite, comfilcon A |
| comfilcon ASubjects will be randomized to wear the comfilcon A contact lenses binocularly. | Device | Phenacite, comfilcon A |
Primary outcome
Subjective Ratings of Lens Comfort
Time frame: Baseline (after 15 minutes of lens dispense)
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Subjective Ratings of Lens Comfort
Time frame: 2 Weeks
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Over Refraction for Optimized Distance Acuity
Time frame: 2 weeks
Over Refraction for optimized distance acuity measured using logMAR
Binocular Distance Visual Acuity - High Illumination High Contrast
Time frame: Baseline (after 5 minutes of lens dispense)
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Binocular Distance Visual Acuity - High Illumination High Contrast
Time frame: 2 weeks
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Binocular Distance Visual Acuity - Low Illumination High Contrast
Time frame: Baseline (after 5 minutes of lens dispense)
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Binocular Distance Visual Acuity - Low Illumination High Contrast
Time frame: 2 weeks
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Binocular Near Visual Acuity - High Illumination High Contrast
Time frame: Baseline (after 5 minutes of lens dispense)
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Binocular Near Visual Acuity - High Illumination High Contrast
Time frame: 2 weeks
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Binocular Near Visual Acuity - Low Illumination High Contrast
Time frame: Baseline (after 5 minutes of lens dispense)
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Binocular Near Visual Acuity - Low Illumination High Contrast
Time frame: 2 weeks
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
18 secondary outcomes
Lens Fit - Post Blink Movement
Time frame: Baseline (after 15 minutes of lens dispense)
Lens Fit - Post Blink Movement
Time frame: 2 weeks
Push - Up Test for Lens Tightness
Time frame: Baseline (after 15 minutes of lens dispense)
Push - Up Test for Lens Tightness
Time frame: 2 weeks
Lens Mobility Rating
Time frame: Baseline (after 15 minutes of lens dispense)
Lens Mobility Rating
Time frame: 2 weeks
Overall Lens Fit Acceptance
Time frame: Baseline (after 15 minutes of lens dispense)
Overall Lens Fit Acceptance
Time frame: 2 weeks
Subjective Ratings for Vision Quality - Distance Vision
Time frame: Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Distance Vision
Time frame: 2 weeks
Subjective Ratings for Vision Quality - Near Vision
Time frame: Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Near Vision
Time frame: 2 weeks
Subjective Ratings for Vision Quality - Computer Vision
Time frame: Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Computer Vision
Time frame: 2 weeks
Subjective Ratings for Vision Quality - Overall Vision
Time frame: Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Overall Vision
Time frame: 2 weeks
Corneal Staining Extent
Time frame: 2 weeks
Conjunctival Staining
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- 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.
Pete Kollbaun, OD PhD principal investigator
CORL Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenacite and comfilcon A in people with Ametropia, run by CooperVision, Inc. 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 11 inclusion and 13 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 18 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2020). 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?
Subjective Ratings of Lens Comfort (time frame: Baseline (after 15 minutes of lens dispense)). The study lists 11 primary outcomes in all. 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 18 Nov 2020.