PresbyopiaNCT01526902
Proclear 1-D Multifocal Nondispensing Study
A study testing omafilcon A / PC 1-D MF and lotrafilcon B / Air Optix MF in people with Presbyopia, run by CooperVision, Inc. at 1 site in United States.
Trial summary
This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- omafilcon A / PC 1-D MF and lotrafilcon B / Air Optix MF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 40 and 65 years of age (inclusive)
- Require a reading addition of +1.25 to +2.50D (inclusive)
- Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
- Spectacle cylinder less than or equal to 0.75D in both eyes.
- Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
- Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
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- Have a minimum 2 weeks soft contact lens experience
- Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
- Able to read, comprehend and sign an informed consent
- Willing to comply with the wear and study visit schedule
- Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
- No gas permeable contact lens wear for 1 month prior to the study
Who cannot join
- To be eligible for the study, each candidate must not present with any of the following
- Any active corneal infection, injury, inflammation, or ocular abnormality
- Systemic or ocular allergies, which might interfere with contact lens wear
- Systemic disease, which might interfere with contact lens wear
- Ocular disease, which might interfere with contact lens wear
- Pregnant or lactating
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- Strabismus/amblyopia
- Habitually uncorrected anisometropia greater than or equal to 2.00 D
- Subjects who have undergone corneal refractive surgery
- Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Optics Research Lab, Indiana University,
Bloomington, Indiana, 47405
About this study
This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.
Read the detailed description
The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).
- Conditions
- Presbyopia
- Being tested
- omafilcon A / PC 1-D MF, lotrafilcon B / Air Optix MF
- Keywords
- contact lenses
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omafilcon A / PC 1-D MFDevice
Also called Proclear Multifocal daily wear soft contact lenses
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
lotrafilcon B / Air Optix MFDevice
Also called Air OPtix Aqua Multifocal extended wear soft contact lenses
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses
| Study group | Role | What they receive |
|---|---|---|
| omafilcon A / PC 1-D MF | Active comparator | omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF)
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. Receives: Device: omafilcon A / PC 1-D MF; Device: lotrafilcon B / Air Optix MF |
| lotrafilcon B / Air Optix MF | Active comparator | lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF)
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. Receives: Device: omafilcon A / PC 1-D MF; Device: lotrafilcon B / Air Optix MF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Vision Assessments: High Contrast Distance Visual Acuity
Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Measured: After 1 hour of lens wear
Objective Vision Assessments: High Contrast Intermediate Visual Acuity
Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Measured: After 1 hour of lens wear
Objective Vision Assessments: High Contrast Near Visual Acuity
Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Measured: After 1 hour of lens wear
Secondary outcomes (3)
Subjective Overall Vision: High Contrast Distance Visual Quality
Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
Measured: After 1 hour of lens wear
Subjective Vision Assessments: High Contrast Intermediate Visual Quality
Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
Measured: After 1 hour of lens wear
Subjective Vision Assessments: High Contrast Near Visual Quality
Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
Measured: After 1 hour of lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
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
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Kollbaum, OD, PhD, Principal investigator, Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526902
- Sponsor's protocol ID
- CV-12-02A
- Status last verified
- Mar 2014
- First submitted
- 2 Feb 2012
- Last updated
- 7 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proclear 1-D Multifocal Nondispensing Study
- ClinicalTrials.gov ID
- NCT01526902
- Acronym / sponsor ID
- CV-12-02A
- Conditions
- Presbyopia
- Keywords
- contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.
Detailed description
The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omafilcon A / PC 1-D MF | Active comparator | Device: omafilcon A / PC 1-D MF, Device: lotrafilcon B / Air Optix MFomafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF) Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. |
| lotrafilcon B / Air Optix MF | Active comparator | Device: omafilcon A / PC 1-D MF, Device: lotrafilcon B / Air Optix MFlotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF) Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be between 40 and 65 years of age (inclusive)
- Require a reading addition of +1.25 to +2.50D (inclusive)
- Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
- Spectacle cylinder less than or equal to 0.75D in both eyes.
- Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
Key exclusion criteria (10 listed)
- To be eligible for the study, each candidate must not present with any of the following
- Any active corneal infection, injury, inflammation, or ocular abnormality
- Systemic or ocular allergies, which might interfere with contact lens wear
- Systemic disease, which might interfere with contact lens wear
- Ocular 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 |
|---|---|---|
| omafilcon A / PC 1-D MFAlso: Proclear Multifocal daily wear soft contact lensesSubjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. | Device | lotrafilcon B / Air Optix MF, omafilcon A / PC 1-D MF |
| lotrafilcon B / Air Optix MFAlso: Air OPtix Aqua Multifocal extended wear soft contact lensesSubjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses | Device | lotrafilcon B / Air Optix MF, omafilcon A / PC 1-D MF |
Primary outcome
Objective Vision Assessments: High Contrast Distance Visual Acuity
Time frame: After 1 hour of lens wear
Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Objective Vision Assessments: High Contrast Intermediate Visual Acuity
Time frame: After 1 hour of lens wear
Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Objective Vision Assessments: High Contrast Near Visual Acuity
Time frame: After 1 hour of lens wear
Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
3 secondary outcomes
Subjective Overall Vision: High Contrast Distance Visual Quality
Time frame: After 1 hour of lens wear
Subjective Vision Assessments: High Contrast Intermediate Visual Quality
Time frame: After 1 hour of lens wear
Subjective Vision Assessments: High Contrast Near Visual Quality
Time frame: After 1 hour of lens wear
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- 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.
Peter Kollbaum, OD, PhD principal investigator
Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omafilcon A / PC 1-D MF and lotrafilcon B / Air Optix MF in people with Presbyopia, run by CooperVision, Inc. at 1 site 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 12 inclusion and 10 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 7 Apr 2014. 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 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 6 Mar 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?
Objective Vision Assessments: High Contrast Distance Visual Acuity (time frame: After 1 hour of lens wear). 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 7 Apr 2014.