Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)NCT03466060
Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
A study testing Opti-Free : RevitaLens / Clear Care : RevitaLens, Opti-Free : RevitaLens / RevitaLens : Clear Care and Clear Care : RevitaLens/ Opti-Free : RevitaLens in people with Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment), run by Johnson & Johnson Vision Care, Inc. at 5 sites in United States.
Trial summary
This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)
- What is being tested?
- Opti-Free : RevitaLens / Clear Care : RevitaLens, Opti-Free : RevitaLens / RevitaLens : Clear Care and Clear Care : RevitaLens/ Opti-Free : RevitaLens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Feb 2018to 19 Jun 2018
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Subjects must be 18-69 years of age (inclusive).
- Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
- Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
- The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
- The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
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- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
- Subjects must read, understand, and sign the Statement of Informed Consent.
- Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or breast-feeding.
- Diabetes
- Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
- Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
- Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
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- Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
- Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
- Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
- Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
- Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
- Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
- History of any ocular or corneal surgery (eg, RK, PRK, LASIK).
- Habitual contact lens wear modality as extended wear.
- Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Habitual wearers of rigid gas permeable lens within the past 3 months.
- Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Southern California College of Optometry
Anaheim, California, 92807
University of California, Berkeley School of Optometry
Berkeley, California, 94720
The Ohio State University
Columbus, Ohio, 43210
University of Houston College of Optometry
Houston, Texas, 77240
Vue Optical Boutique
Jacksonville, Florida, 32205
About this study
This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.
- Being tested
- Opti-Free : RevitaLens / Clear Care : RevitaLens, Opti-Free : RevitaLens / RevitaLens : Clear Care, Clear Care : RevitaLens/ Opti-Free : RevitaLens, Clear Care : RevitaLens / RevitaLens : Opti-Free, RevitaLens : Clear Care/ Opti-Free : RevitaLens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opti-Free : RevitaLens / Clear Care : RevitaLensDevice
Also called Right eye : left eye / right eye : left eye
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Opti-Free : RevitaLens / RevitaLens : Clear CareDevice
Also called Right eye : left eye / right eye : left eye
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens/ Opti-Free : RevitaLensDevice
Also called Right eye : left eye / right eye : left eye
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens / RevitaLens : Opti-FreeDevice
Also called Right eye : left eye / right eye : left eye
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care/ Opti-Free : RevitaLensDevice
Also called Right eye : left eye / right eye : left eye
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care / RevitaLens : Opti-FreeDevice
Also called Right eye : left eye / right eye : left eye
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opti-Free / Clear Care : RevitaLensDevice
Also called Right eye : left eye / right eye : left eye
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opit-Free / RevitaLens : Clear CareDevice
Also called Right eye : left eye / right eye : left eye
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A | Active comparator | Eligible subjects were randomized to the etafilcon A lens in both eyes throughout the entire duration of the study. Receives: Device: Opti-Free : RevitaLens / Clear Care : RevitaLens; Device: Opti-Free : RevitaLens / RevitaLens : Clear Care; Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens; Device: Clear Care : RevitaLens / RevitaLens : Opti-Free; Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens; Device: RevitaLens : Clear Care / RevitaLens : Opti-Free; Device: RevitaLens : Opti-Free / Clear Care : RevitaLens; Device: RevitaLens : Opit-Free / RevitaLens : Clear Care |
| senofilcon A | Active comparator | Eligible subjects were randomized to the senofilcon A lens in both eyes throughout the entire duration of the study. Receives: Device: Opti-Free : RevitaLens / Clear Care : RevitaLens; Device: Opti-Free : RevitaLens / RevitaLens : Clear Care; Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens; Device: Clear Care : RevitaLens / RevitaLens : Opti-Free; Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens; Device: RevitaLens : Clear Care / RevitaLens : Opti-Free; Device: RevitaLens : Opti-Free / Clear Care : RevitaLens; Device: RevitaLens : Opit-Free / RevitaLens : Clear Care |
| senofilcon C | Active comparator | Eligible subjects were randomized to the senofilcon C lens in both eyes throughout the entire duration of the study. Receives: Device: Opti-Free : RevitaLens / Clear Care : RevitaLens; Device: Opti-Free : RevitaLens / RevitaLens : Clear Care; Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens; Device: Clear Care : RevitaLens / RevitaLens : Opti-Free; Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens; Device: RevitaLens : Clear Care / RevitaLens : Opti-Free; Device: RevitaLens : Opti-Free / Clear Care : RevitaLens; Device: RevitaLens : Opit-Free / RevitaLens : Clear Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Comfort
Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.
Measured: Up to 2-Hours Post Lens Fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start7 Feb 2018
- Primary completion19 Jun 2018
- Study completion19 Jun 2018
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 Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)Studies 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
- 130 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
- NCT03466060
- Sponsor's protocol ID
- CR-6012
- Status last verified
- Sep 2019
- First submitted
- 26 Feb 2018
- Last updated
- 2 Oct 2019
- 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 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
- ClinicalTrials.gov ID
- NCT03466060
- Acronym / sponsor ID
- CR-6012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etafilcon A | Active comparator | Device: Opti-Free : RevitaLens / Clear Care : RevitaLens, Device: Opti-Free : RevitaLens / RevitaLens : Clear Care, Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens, Device: Clear Care : RevitaLens / RevitaLens : Opti-Free, Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens, Device: RevitaLens : Clear Care / RevitaLens : Opti-Free, Device: RevitaLens : Opti-Free / Clear Care : RevitaLens, Device: RevitaLens : Opit-Free / RevitaLens : Clear CareEligible subjects were randomized to the etafilcon A lens in both eyes throughout the entire duration of the study. |
| senofilcon A | Active comparator | Device: Opti-Free : RevitaLens / Clear Care : RevitaLens, Device: Opti-Free : RevitaLens / RevitaLens : Clear Care, Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens, Device: Clear Care : RevitaLens / RevitaLens : Opti-Free, Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens, Device: RevitaLens : Clear Care / RevitaLens : Opti-Free, Device: RevitaLens : Opti-Free / Clear Care : RevitaLens, Device: RevitaLens : Opit-Free / RevitaLens : Clear CareEligible subjects were randomized to the senofilcon A lens in both eyes throughout the entire duration of the study. |
| senofilcon C | Active comparator | Device: Opti-Free : RevitaLens / Clear Care : RevitaLens, Device: Opti-Free : RevitaLens / RevitaLens : Clear Care, Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens, Device: Clear Care : RevitaLens / RevitaLens : Opti-Free, Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens, Device: RevitaLens : Clear Care / RevitaLens : Opti-Free, Device: RevitaLens : Opti-Free / Clear Care : RevitaLens, Device: RevitaLens : Opit-Free / RevitaLens : Clear CareEligible subjects were randomized to the senofilcon C lens in both eyes throughout the entire duration of the study. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Key exclusion criteria (18 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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 |
|---|---|---|
| Opti-Free : RevitaLens / Clear Care : RevitaLensAlso: Right eye : left eye / right eye : left eyeSubjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits. | Device | etafilcon A, senofilcon A, senofilcon C |
| Opti-Free : RevitaLens / RevitaLens : Clear CareAlso: Right eye : left eye / right eye : left eyeSubjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits. | Device | etafilcon A, senofilcon A, senofilcon C |
| Clear Care : RevitaLens/ Opti-Free : RevitaLensAlso: Right eye : left eye / right eye : left eyeSubjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits. | Device | etafilcon A, senofilcon A, senofilcon C |
| Clear Care : RevitaLens / RevitaLens : Opti-FreeAlso: Right eye : left eye / right eye : left eyeSubjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits. | Device | etafilcon A, senofilcon A, senofilcon C |
| RevitaLens : Clear Care/ Opti-Free : RevitaLensAlso: Right eye : left eye / right eye : left eyeSubjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits. | Device | etafilcon A, senofilcon A, senofilcon C |
| RevitaLens : Clear Care / RevitaLens : Opti-FreeAlso: Right eye : left eye / right eye : left eyeSubjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits. | Device | etafilcon A, senofilcon A, senofilcon C |
| RevitaLens : Opti-Free / Clear Care : RevitaLensAlso: Right eye : left eye / right eye : left eyeSubjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits. | Device | etafilcon A, senofilcon A, senofilcon C |
| RevitaLens : Opit-Free / RevitaLens : Clear CareAlso: Right eye : left eye / right eye : left eyeSubjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits. | Device | etafilcon A, senofilcon A, senofilcon C |
Primary outcome
Subject Comfort
Time frame: Up to 2-Hours Post Lens Fitting
Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opti-Free : RevitaLens / Clear Care : RevitaLens, Opti-Free : RevitaLens / RevitaLens : Clear Care and Clear Care : RevitaLens/ Opti-Free : RevitaLens in people with Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment), run by Johnson & Johnson Vision Care, Inc. at 5 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 18 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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 Oct 2019). 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?
Subject Comfort (time frame: Up to 2-Hours Post Lens Fitting). 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 2 Oct 2019.