PresbyopiaNCT02450747
Performance of a Multifocal Contact Lens - Presbyopia Study
A study testing etafilcon A MULTIFOCAL in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.
Trial summary
This is a four week study to evaluate the performance of a multifocal contact lens in habitual wearers of silicone hydrogel multifocal contact lenses. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- etafilcon A MULTIFOCAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Sep 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult males or females age 40 to 70 and has full legal capacity to volunteer.
- The subject is a current spherical silicone hydrogel multifocal (SiHy) contact lens wearer (defined as a minimum of 2 days per week for at least 6 hours of Daily Wear contact lenses, for a minimum of one month prior to the study) and willing to wear the study lenses on a daily basis (defined as a minimum of 6 hours of wear per day) for the duration of the study.
- The subject must own a pair of wearable spectacles to wear when they cannot wear the study lenses.
- The subject's optimal vertexed spherical equivalent distance correction must be between +3.50 and -5.50 Diopters (D) (inclusive) in both eyes.
- Subjective refraction cylinder power must be less than or equal to 0.75 D in both eyes.
- Requires a reading addition of +0.75 D to +2.50 D in each eye.
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- The subject must have distance and near visual acuity best correctable to logMAR 0.1 (20/25) or better at both distance and near with subjective refraction for each eye.
- The subject must read and sign the Informed Consent form.
- The subject must appear able and willing to adhere the instructions set forth in this clinical protocol.
Who cannot join
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Participant in unrelated research clinical trial within 30 days prior to enrollment;
- Known to have any infectious disease (e.g.hepatitis, tuberculosis) or a contagious immunosuppressive disease.
- Women who are pregnant or lactating or planning a pregnancy at the time of enrollment;
- Ocular or systemic allergies or disease which might interfere with contact lens wear;
- Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
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- Systemic disease or use of medication which might interfere with contact lens wear;
- Any corneal distortion;
- Has any known active* ocular disease and/or infection;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; and only uses rewetting drops on an occasional basis( greater than 2 times per week).
- Is a habitual monovision contact lens wearer wearing contact lenses on extended wear basis or for the past 6 months;
- Diagnosed with Diabetes;
- Is aphakic; or Has entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
- Has undergone refractive error surgery;
- Has amblyopia or strabismus;
- Has anisometropia >2 D between both eyes;
- Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Any grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron 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;
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Trial locations and contacts
1 site in 1 country.
About this study
This is a four week study to evaluate the performance of a multifocal contact lens in habitual wearers of silicone hydrogel multifocal contact lenses.
- Conditions
- Presbyopia
- Being tested
- etafilcon A MULTIFOCAL
- Keywords
- Visual Acuity
- 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 MULTIFOCALDevice
Subjects will wear the test lens for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Multifocal Test Contact Lens | Experimental | Subjects will wear the etafilcon A Multifocal test lens in a daily wear modality. Receives: Device: etafilcon A MULTIFOCAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Grade of Conjunctival Hyperemia
Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia
Measured: Baseline to 4-Week Follow-up
Upper Lid Margin Staining Score
Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.
Measured: Baseline to 4-Week Follow-up
Average Corneal Staining Area Grade
Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.
Measured: Baseline to 4- 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 posted21 May 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT02450747
- Sponsor's protocol ID
- CR-5692
- Status last verified
- Nov 2016
- First submitted
- 17 Apr 2015
- 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
- Performance of a Multifocal Contact Lens - Presbyopia Study
- ClinicalTrials.gov ID
- NCT02450747
- Acronym / sponsor ID
- CR-5692
- Conditions
- Presbyopia
- Keywords
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Posted 12 Jan 2017
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 four week study to evaluate the performance of a multifocal contact lens in habitual wearers of silicone hydrogel multifocal contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifocal Test Contact Lens | Experimental | Device: etafilcon A MULTIFOCALSubjects will wear the etafilcon A Multifocal test lens in a daily wear modality. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy adult males or females age 40 to 70 and has full legal capacity to volunteer.
- The subject is a current spherical silicone hydrogel multifocal (SiHy) contact lens wearer (defined as a minimum of 2 days per week for at least 6 hours of Daily Wear contact lenses, for a minimum of one month prior to the study) and willing to wear the study lenses on a daily basis (defined as a minimum of 6 hours of wear per day) for the duration of the study.
- The subject must own a pair of wearable spectacles to wear when they cannot wear the study lenses.
- The subject's optimal vertexed spherical equivalent distance correction must be between +3.50 and -5.50 Diopters (D) (inclusive) in both eyes.
- Subjective refraction cylinder power must be less than or equal to 0.75 D in both eyes.
Key exclusion criteria (19 listed)
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Participant in unrelated research clinical trial within 30 days prior to enrollment;
- Known to have any infectious disease (e.g.hepatitis, tuberculosis) or a contagious immunosuppressive disease.
- Women who are pregnant or lactating or planning a pregnancy at the time of enrollment;
- Ocular or systemic allergies or disease which might interfere with contact lens wear;
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 MULTIFOCALSubjects will wear the test lens for four weeks. | Device | Multifocal Test Contact Lens |
Primary outcome
The Total Grade of Conjunctival Hyperemia
Time frame: Baseline to 4-Week Follow-up
Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia
Upper Lid Margin Staining Score
Time frame: Baseline to 4-Week Follow-up
Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.
Average Corneal Staining Area Grade
Time frame: Baseline to 4- Week Follow-up
Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.
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.
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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.
1 site 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 in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.
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 9 inclusion and 19 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 1 site in Canada. 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 12 Jan 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?
The Total Grade of Conjunctival Hyperemia (time frame: Baseline to 4-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 Jun 2018.