Visual AcuityNCT02982018
Clinical Evaluation of Approved and Investigational Contact Lenses Using New UV Additive
A study testing senofilcon A with new UV blocker and senofilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 sites in United States.
Trial summary
Randomized, 8-visit dispensing study over 14 weeks to evaluate the safety and efficacy of an investigational contact lens with a new UV blocker compared to a marketed contact lens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- senofilcon A with new UV blocker and senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Oct 2016to 18 Feb 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must read and sign the Informed Consent form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Healthy adult males or females age ≥ 18 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopters (D).
- The subject's refractive cylinder must be ≤ 1.00 D in each eye.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
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- Subjects should own a wearable pair of spectacles.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
- Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Who cannot join
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. Seldane, Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- Any previous, or planned, ocular or interocular surgery (e.g.., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
- Any grade 2 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.
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- Any known hypersensitivity or allergic reaction to Optifree®Puremoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
- Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Toric, extended wear, monovision or multi-focal contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Closter, New Jersey, 07624
Study site
Jacksonville, Florida, 32205
Study site
Longwood, Florida, 32779
Study site
Pickens, South Carolina, 29671
Study site
Sarasota, Florida, 34242
Study site
Vestal, New York, 13850
About this study
Randomized, 8-visit dispensing study over 14 weeks to evaluate the safety and efficacy of an investigational contact lens with a new UV blocker compared to a marketed contact lens.
- Conditions
- Visual Acuity
- Being tested
- senofilcon A with new UV blocker, senofilcon A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon A with new UV blockerDevice
Investigational Contact Lens
senofilcon ADevice
J\&J Marketed Contact Lens
| Study group | Role | What they receive |
|---|---|---|
| Investigational Contact Lens with UV Blocker | Experimental | Subjects will be dispensed the investigational contact lens with UV blocker to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits. Receives: Device: senofilcon A with new UV blocker |
| Marketed Contact Lens | Active comparator | Subjects will be dispensed the marketed contact lens to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits. Receives: Device: senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyestrain Related to Glare
Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.
Measured: Up to 12-Week Follow-up
Distance Monocular logMAR Visual Acuity (VA)
Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.
Measured: Up to 12-Week Follow-up
Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings
Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.
Measured: Up to 12-Week Follow-up
Secondary outcomes (2)
Contact Lens Wearing Time
Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported.
Measured: Up to 12-Week Follow-up
Percentage of Eyes With Subject Reported Symptoms Problems or Complaints
Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point.
Measured: Up to 12-Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 Oct 2016
- Primary completion18 Feb 2017
- Study completion18 Feb 2017
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 133 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
- NCT02982018
- Sponsor's protocol ID
- CR-5638
- Status last verified
- Jul 2018
- First submitted
- 31 Oct 2016
- Last updated
- 19 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Approved and Investigational Contact Lenses Using New UV Additive
- ClinicalTrials.gov ID
- NCT02982018
- Acronym / sponsor ID
- CR-5638
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 18 Feb 2017 (actual)
- Study completion
- 18 Feb 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 19 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, 8-visit dispensing study over 14 weeks to evaluate the safety and efficacy of an investigational contact lens with a new UV blocker compared to a marketed contact lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Contact Lens with UV Blocker | Experimental | Device: senofilcon A with new UV blockerSubjects will be dispensed the investigational contact lens with UV blocker to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits. |
| Marketed Contact Lens | Active comparator | Device: senofilcon ASubjects will be dispensed the marketed contact lens to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject must read and sign the Informed Consent form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Healthy adult males or females age ≥ 18 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopters (D).
- The subject's refractive cylinder must be ≤ 1.00 D in each eye.
Key exclusion criteria (13 listed)
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. Seldane, Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- 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 |
|---|---|---|
| senofilcon A with new UV blockerInvestigational Contact Lens | Device | Investigational Contact Lens with UV Blocker |
| senofilcon AJ\&J Marketed Contact Lens | Device | Marketed Contact Lens |
Primary outcome
Eyestrain Related to Glare
Time frame: Up to 12-Week Follow-up
Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.
Distance Monocular logMAR Visual Acuity (VA)
Time frame: Up to 12-Week Follow-up
Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.
Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings
Time frame: Up to 12-Week Follow-up
Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.
2 secondary outcomes
Contact Lens Wearing Time
Time frame: Up to 12-Week Follow-up
Percentage of Eyes With Subject Reported Symptoms Problems or Complaints
Time frame: Up to 12-Week Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon A with new UV blocker and senofilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. 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 10 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 19 Jul 2018. 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?
Yes. Results are posted in the registry (first posted 19 Jul 2018). 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?
Eyestrain Related to Glare (time frame: Up to 12-Week Follow-up). The study lists 3 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 19 Jul 2018.