MyopiaNCT01094743
Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens
A study testing galyfilcon A prototype lens and lotrafilcon B lens in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Myopia
- What is being tested?
- galyfilcon A prototype lens and lotrafilcon B lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2010to 1 Mar 2010
- 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 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject must be at least 18 years of age and no more than 39 years of age.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
- Any cylinder power must be ≤ -0.75D.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- The subject must read and sign the Statement of Informed Consent.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Who cannot join
- Ocular or systemic allergies or disease which might interfere with contact lens wear.
- Systemic disease or use of medication which might interfere with contact lens wear.
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
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- Pregnancy or lactation.
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Jacksonville, Florida
Study site
Salem, Virginia
About this study
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
- Conditions
- Myopia
- Being tested
- galyfilcon A prototype lens, lotrafilcon B lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galyfilcon A prototype lensDevice
Silicone hydrogel contact lens
lotrafilcon B lensDevice
Silicon Hydrogel contact lens
| Study group | Role | What they receive |
|---|---|---|
| galyfilcon A prototype lens / lotrafilcon B lens | Other | The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week. Receives: Device: galyfilcon A prototype lens; Device: lotrafilcon B lens |
| lotrafilcon B lens / galyfilcon A prototype lens | Other | The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week. Receives: Device: galyfilcon A prototype lens; Device: lotrafilcon B lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Monocular
Snellen monocular visual acuity measurement
Measured: after 1 week of lens wear
Visual Acuity Binocular
Snellen binocular visual acuity measurement
Measured: after 1 week of lens wear
Subjective Assessment of Lens Comfort
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.
Measured: after 1 week of lens wear
Subjective Assessment of Quality of Vision
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.
Measured: after 1 week of lens wear
Secondary outcomes (3)
Limbal Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Measured: after 1 week of lens wear
Bulbar Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Measured: after 1 week of lens wear
Subjective Assessment of Lens Comfort
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.
Measured: 10 minutes after lens insertion at time of initial lens fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study start1 Feb 2010
- Primary completion1 Mar 2010
- Study completion1 Mar 2010
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 MyopiaStudies 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
- 52 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
- NCT01094743
- Sponsor's protocol ID
- CR-1636AZ
- Status last verified
- Sep 2017
- First submitted
- 24 Mar 2010
- Last updated
- 19 Jun 2018
- 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 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens
- ClinicalTrials.gov ID
- NCT01094743
- Acronym / sponsor ID
- CR-1636AZ
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 1 Mar 2010 (actual)
- Study completion
- 1 Mar 2010 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Posted 25 Jan 2012
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 compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| galyfilcon A prototype lens / lotrafilcon B lens | Other | Device: galyfilcon A prototype lens, Device: lotrafilcon B lensThe galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week. |
| lotrafilcon B lens / galyfilcon A prototype lens | Other | Device: galyfilcon A prototype lens, Device: lotrafilcon B lensThe lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject must be at least 18 years of age and no more than 39 years of age.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
- Any cylinder power must be ≤ -0.75D.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
Key exclusion criteria (10 listed)
- Ocular or systemic allergies or disease which might interfere with contact lens wear.
- Systemic disease or use of medication which might interfere with contact lens wear.
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
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 |
|---|---|---|
| galyfilcon A prototype lensSilicone hydrogel contact lens | Device | galyfilcon A prototype lens / lotrafilcon B lens, lotrafilcon B lens / galyfilcon A prototype lens |
| lotrafilcon B lensSilicon Hydrogel contact lens | Device | galyfilcon A prototype lens / lotrafilcon B lens, lotrafilcon B lens / galyfilcon A prototype lens |
Primary outcome
Visual Acuity Monocular
Time frame: after 1 week of lens wear
Snellen monocular visual acuity measurement
Visual Acuity Binocular
Time frame: after 1 week of lens wear
Snellen binocular visual acuity measurement
Subjective Assessment of Lens Comfort
Time frame: after 1 week of lens wear
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.
Subjective Assessment of Quality of Vision
Time frame: after 1 week of lens wear
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.
3 secondary outcomes
Limbal Redness
Time frame: after 1 week of lens wear
Bulbar Redness
Time frame: after 1 week of lens wear
Subjective Assessment of Lens Comfort
Time frame: 10 minutes after lens insertion at time of initial lens fitting
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing galyfilcon A prototype lens and lotrafilcon B lens in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 2 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 7 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 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 2 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 25 Jan 2012). 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?
Visual Acuity Monocular (time frame: after 1 week of lens wear). The study lists 4 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.