Refractive ErrorNCT02515994
Evaluation of a Johnson & Johnson Vision Care Investigational Contact Lens Compared to a Marketed Monthly Replacement Contact Lens
A study testing senofilcon C and comfilcon A in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 10 sites in United States.
Trial summary
Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing study of Johnson \& Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI investigational contact lenses on a daily wear basis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error
- What is being tested?
- senofilcon C and comfilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2015to Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 at least 18 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
- The subject's refractive cylinder must be ≤ 1.00 Diopters in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Show all 10Show fewer
- Subjects should own a wearable pair of spectacles.
- The subject must be an adapted frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 4 days per week
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 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.
Show all 13Show fewer
- 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.
- Daily disposables, 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Premier Vision
Amarillo, Texas, 79119
Eyecare Associates
Bloomington, Illinois, 61701
Advantage Eyecare Associates, LLC
Broadway Pittsburg, Kansas, 66762
Dr. Debbie H. Kim, OD
Closter, New Jersey, 07624
Vue Optical Boutique
Jacksonville, Florida, 32205
Omega Vision Center, PA / Sabal Eye Care
Longwood, Florida, 32779
Pickens Family Eye Care
Pickens, South Carolina, 29671
Timothy R. Poling, OD
Salem, Virginia, 24153
William J. Bogus OD
Salt Lake City, Utah, 84106
Sacco Eye Group
Vestal, New York, 13850
About this study
Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing study of Johnson \& Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI investigational contact lenses on a daily wear basis.
Read the detailed description
Objective of the study is to demonstrate the safety and efficacy of the JJVCI investigational contact lens by comparison to the marketed, monthly replacement contact lens, both worn for thirty days on a daily wear modality.
- Conditions
- Refractive Error
- Being tested
- senofilcon C, 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.
senofilcon CDevice
Investigational contact lens
comfilcon ADevice
Also called Biofinity
Marketed Monthly Replacement Lens (Control)
| Study group | Role | What they receive |
|---|---|---|
| senofilcon C | Experimental | JJVCI investigational contact lens daily wear replacement. Receives: Device: senofilcon C |
| comfilcon A | Active comparator | Marketed contact lens daily wear replacement. Receives: Device: comfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.
Measured: Up to 3 Month Follow-up
Visual Acuity
Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.
Measured: Up to 3 month Follow-up
Secondary outcomes (2)
Symptoms
Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item "Experienced Eye Symptoms or Problems?" were reported.
Measured: Up to 3 month Follow-up
Average Wear Time
Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.
Measured: 3 month 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 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionNov 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 Refractive ErrorStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 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
- NCT02515994
- Sponsor's protocol ID
- CR-5726
- Status last verified
- Jun 2016
- First submitted
- 3 Aug 2015
- Last updated
- 15 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Johnson & Johnson Vision Care Investigational Contact Lens Compared to a Marketed Monthly Replacement Contact Lens
- ClinicalTrials.gov ID
- NCT02515994
- Acronym / sponsor ID
- CR-5726
- Conditions
- Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Posted 14 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing study of Johnson \& Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI investigational contact lenses on a daily wear basis.
Detailed description
Objective of the study is to demonstrate the safety and efficacy of the JJVCI investigational contact lens by comparison to the marketed, monthly replacement contact lens, both worn for thirty days on a daily wear modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| senofilcon C | Experimental | Device: senofilcon CJJVCI investigational contact lens daily wear replacement. |
| comfilcon A | Active comparator | Device: comfilcon AMarketed contact lens daily wear replacement. |
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, 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 at least 18 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
- The subject's refractive cylinder must be ≤ 1.00 Diopters 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 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 CInvestigational contact lens | Device | senofilcon C |
| comfilcon AAlso: BiofinityMarketed Monthly Replacement Lens (Control) | Device | comfilcon A |
Primary outcome
Slit Lamp Findings
Time frame: Up to 3 Month Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.
Visual Acuity
Time frame: Up to 3 month Follow-up
Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.
2 secondary outcomes
Symptoms
Time frame: Up to 3 month Follow-up
Average Wear Time
Time frame: 3 month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Refractive Error
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon C and comfilcon A in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 10 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 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 14 Jun 2016). 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?
Slit Lamp Findings (time frame: Up to 3 Month 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 15 Jul 2016.