PresbyopiaNCT01016652
Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
A study testing etafilcon A multifocal contact lens and etafilcon A Contact Lens in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients. Read more about this study
- Who is it for?
- Ages 35 to 47 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- etafilcon A multifocal contact lens and etafilcon A Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Oct 2009to 1 Dec 2009
- 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 35 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).
- Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
- Between 35 and 47 years of age (inclusive).
- Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes.
- Refractive astigmatism of 0.75D or less in both eyes.
- Visual symptoms associated with near vision
Show all 13Show fewer
- Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
- Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:
- No amblyopia.
- No evidence of lid abnormality or infection.
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities).
- No other active ocular disease.
Who cannot join
- Monovision user or multifocal CL wearer.
- Regular user of reading spectacles (i.e. daily usage).
- Requires concurrent ocular medication.
- Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear.
- Corneal staining Grade 3 in more than two regions.
- Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
- Pre-existing ocular irritation that would preclude CL fitting.
- Keratoconus or other corneal irregularity.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Blue Springs, Missouri
Study site
Burlington, Vermont
Study site
Chamberlain, South Dakota
Study site
Kittanning, Pennsylvania
Study site
Lake Ozark, Missouri
Study site
North Little Rock, Arkansas
Study site
Warren, Ohio
Study site
Warwick, Rhode Island
About this study
The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
- Conditions
- Presbyopia
- Being tested
- etafilcon A multifocal contact lens, etafilcon A Contact Lens
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon A multifocal contact lensDevice
low-add multifocal contact lens
etafilcon A Contact LensDevice
standard sphere contact lens
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A multifocal / etafilcon A sphere | Other | period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn. Receives: Device: etafilcon A multifocal contact lens; Device: etafilcon A Contact Lens |
| etafilcon A sphere / etafilcon A multifocal | Other | period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn. Receives: Device: etafilcon A multifocal contact lens; Device: etafilcon A Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.
Measured: week 4
Monocular Amplitude of Accommodation
The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.
Measured: week 4
Secondary outcomes (4)
Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ
Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).
Measured: week 4
Subject Reported Lens Comfort Using CLUE Questionnaire
Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120.
Measured: week 4
Comfortable Wearing Time
Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.
Measured: week 4
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper
Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study start1 Oct 2009
- Primary completion1 Dec 2009
- Study completion1 Dec 2009
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 PresbyopiaStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016652
- Sponsor's protocol ID
- CR-4558
- Other IDs
- VMFL-511
- Status last verified
- Aug 2017
- First submitted
- 18 Nov 2009
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
- ClinicalTrials.gov ID
- NCT01016652
- Acronym / sponsor ID
- CR-4558
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- 1 Dec 2009 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Posted 23 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etafilcon A multifocal / etafilcon A sphere | Other | Device: etafilcon A multifocal contact lens, Device: etafilcon A Contact Lensperiod 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn. |
| etafilcon A sphere / etafilcon A multifocal | Other | Device: etafilcon A multifocal contact lens, Device: etafilcon A Contact Lensperiod 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn. |
Who may qualify
- Ages
- 35 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- To have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).
- Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
- Between 35 and 47 years of age (inclusive).
- Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes.
- Refractive astigmatism of 0.75D or less in both eyes.
Key exclusion criteria (8 listed)
- Monovision user or multifocal CL wearer.
- Regular user of reading spectacles (i.e. daily usage).
- Requires concurrent ocular medication.
- Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear.
- Corneal staining Grade 3 in more than two regions.
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 |
|---|---|---|
| etafilcon A multifocal contact lenslow-add multifocal contact lens | Device | etafilcon A multifocal / etafilcon A sphere, etafilcon A sphere / etafilcon A multifocal |
| etafilcon A Contact Lensstandard sphere contact lens | Device | etafilcon A multifocal / etafilcon A sphere, etafilcon A sphere / etafilcon A multifocal |
Primary outcome
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
Time frame: week 4
The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.
Monocular Amplitude of Accommodation
Time frame: week 4
The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.
4 secondary outcomes
Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ
Time frame: week 4
Subject Reported Lens Comfort Using CLUE Questionnaire
Time frame: week 4
Comfortable Wearing Time
Time frame: week 4
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etafilcon A multifocal contact lens and etafilcon A Contact Lens in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 8 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 13 inclusion and 8 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 23 Jan 2014). 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 Reported Overall Vision Quality Using (CLUE)TM Questionnaire (time frame: week 4). 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 19 Jun 2018.