Visual AcuityNCT02759692
Clinical Evaluation of Two Approved Contact Lenses
A study testing TEST Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 13 sites in United States.
Trial summary
Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- TEST Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Apr 2016to 1 Jun 2016
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between (and including) 18 and 39 years of age.
- The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day, worn for at least 30 days immediately preceding the study.
- Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye.
- Have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Who cannot join
- Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any autoimmune disease or use of medication, which may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Show all 12Show fewer
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Monovision, multi-focal, toric, or extended wear contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
- Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Advanced Family Eye Care
Denver, North Carolina, 28037
Complete Family Eye Care of Fruit Cove
Jacksonville, Florida, 32259
Brian Frazier, OD
Jacksonville, Texas, 17576
Total Eye Care PA
Memphis, Tennessee, 38119
Becky Bizzle, OD
Montgomery, Alabama, 36117
Advantage Eyecare Associates, LLC
Neodesha, Kansas, 66757
VisualEyes, Inc.
Roswell, Georgia, 30076
Timothy R. Poling, OD
Salem, Virginia, 24153
Golden Family Eyecare
Sarasota, Florida, 34232
St. Lucy's Vision Center
Tampa, Florida, 33625
Sacco Eye Group
Vestal, New York, 13850
Ziegler Leffingwell Eyecare
West Allis, Wisconsin, 53227
Eye Associates of Winter Park
Winter Park, Florida, 32792
About this study
Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.
- Conditions
- Visual Acuity
- Being tested
- TEST Contact Lens, CONTROL Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEST Contact LensDevice
Also called senofilcon A
CONTROL Contact LensDevice
Also called stenfilcon A
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Test/Control/Test) | Active comparator | Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL / TEST wearing sequence will wear lenses as daily disposable on both eyes for approximately one week each with no washout period between lenses for at least five days, and 8 hours per day. Receives: Device: TEST Contact Lens; Device: CONTROL Contact Lens |
| Group 2 (Control/Test/Control) | Active comparator | Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST / CONTROL wearing sequence will wear lenses as daily disposable on both eyes for approximately one week each with no washout period between lenses for at least five days, and 8 hours per day. Receives: Device: TEST Contact Lens; Device: CONTROL Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Comfort
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.
Measured: 7-Day Follow-up
Overall Quality of Vision
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.
Measured: 7-Day Follow-up
Secondary outcomes (4)
Individual Patient Reported Outcomes (Items 1-5)
Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)1."These Lenses Were Very Comfortable At The End Of The Day" 2."The Comfort of these lenses decreased throughout the day" 3. The lenses were very comfortable from the time I got up to the time I went to bed" 4. "Overall Comfort" 5. "Comfort throughout the Day"
Measured: 7-Day Follow-up
Individual Patient Reported Outcomes (Items 6-10)
Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)6. "Comfort at the end of the day" 7. They remained comfortable from the moment I put them in until the moment I took them out" 8."Comfort from activity to activity" 9. Comfort across different environments" 10."Comfort while working on a computer"
Measured: 7-Day Follow-up
Individual Patient Reported Outcomes (Items 11-14)
Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 11."I was very satisfied with my distance vision when i first put these lenses in my eyes. 12."I was very satisfied by the clarity of my vision at the end of the day" 13."I was satisfied with the quality of my vision at night" 14."With these lenses, I felt very confident to drive at night"
Measured: 7-Day Follow-up
Individual Patient Reported Outcomes (Items 15-17)
Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 15."Clarity of vision during daily activities" 16."Clarity of vision in dim or low lighting conditions" 17. "Clarity of visions when driving at night".
Measured: 7-Day Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start1 Apr 2016
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
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 Visual AcuityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759692
- Sponsor's protocol ID
- CR-5829
- Status last verified
- Jul 2017
- First submitted
- 29 Apr 2016
- Last updated
- 18 Aug 2017
- 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 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two Approved Contact Lenses
- ClinicalTrials.gov ID
- NCT02759692
- Acronym / sponsor ID
- CR-5829
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Test/Control/Test) | Active comparator | Device: TEST Contact Lens, Device: CONTROL Contact LensSubjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL / TEST wearing sequence will wear lenses as daily disposable on both eyes for approximately one week each with no washout period between lenses for at least five days, and 8 hours per day. |
| Group 2 (Control/Test/Control) | Active comparator | Device: TEST Contact Lens, Device: CONTROL Contact LensSubjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST / CONTROL wearing sequence will wear lenses as daily disposable on both eyes for approximately one week each with no washout period between lenses for at least five days, and 8 hours per day. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between (and including) 18 and 39 years of age.
- The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day, worn for at least 30 days immediately preceding the study.
- Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye.
Key exclusion criteria (12 listed)
- Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any autoimmune disease or use of medication, which may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
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 |
|---|---|---|
| TEST Contact LensAlso: senofilcon A | Device | Group 1 (Test/Control/Test), Group 2 (Control/Test/Control) |
| CONTROL Contact LensAlso: stenfilcon A | Device | Group 1 (Test/Control/Test), Group 2 (Control/Test/Control) |
Primary outcome
Overall Comfort
Time frame: 7-Day Follow-up
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.
Overall Quality of Vision
Time frame: 7-Day Follow-up
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.
4 secondary outcomes
Individual Patient Reported Outcomes (Items 1-5)
Time frame: 7-Day Follow-up
Individual Patient Reported Outcomes (Items 6-10)
Time frame: 7-Day Follow-up
Individual Patient Reported Outcomes (Items 11-14)
Time frame: 7-Day Follow-up
Individual Patient Reported Outcomes (Items 15-17)
Time frame: 7-Day Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- 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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEST Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 13 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 7 inclusion and 12 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Yes. Results are posted in the registry (first posted 18 Aug 2017). 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?
Overall Comfort (time frame: 7-Day Follow-up). The study lists 2 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 Aug 2017.