MyopiaNCT01155323
Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses
A study testing etafilcon A and omafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Singapore.
Trial summary
This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Myopia
- What is being tested?
- etafilcon A and omafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2010to 1 Jun 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
- At least 18 years of age and no more than 39 years of age
- Existing soft contact lens wearers
- Willing to signed a written Informed Consent.
- Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
- Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
- Have an Astigmatism of 1.00D or less in both eyes.
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- Require a visual correction in both eyes.
- 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 that would preclude lens wear.
Who cannot join
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Clinically significant corneal staining (Grade 3 in more than one region).
- Keratoconus or other corneal irregularity.
- Abnormal lachrymal secretions.
- Extended wear of contact lenses last 3 months.
- Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
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- Refractive surgery.
- Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Require concurrent ocular medication
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
- Diabetes.
- Pregnant, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial or in last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study
This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.
- Conditions
- Myopia
- Being tested
- etafilcon A, omafilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon ADevice
1-day soft contact lens
omafilcon ADevice
1-day soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A/omafilcon A | Active comparator | etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily Receives: Device: etafilcon A; Device: omafilcon A |
| omafilcon A/etafilcon A | Active comparator | omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily. Receives: Device: etafilcon A; Device: omafilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Rating of Comfort
This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Measured: after 1 week of lens wear
Vision Quality
This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Measured: after 1 week of lens wear
Subjective Rating of Handling
This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Measured: after 1 week of lens wear
Corneal Staining
Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Measured: after 1 week of lens wear
Subjective Rating of Quality Perceptions
This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Measured: after 1 week of lens wear
Limbal Hyperemia
This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.
Measured: after 1 week of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study start1 Mar 2010
- Primary completion1 Jun 2010
- Study completion1 Jun 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson K.K. Medical Company, Visioncare Research Ltd.
- Responsible party
- Sponsor
- Investigators
- Danny Sim, Diploma in Optometry, Principal investigator, Singapore Polytechnic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155323
- Sponsor's protocol ID
- CR-0926
- Other IDs
- DISP-523
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2010
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
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
- Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study
- ClinicalTrials.gov ID
- NCT01155323
- Acronym / sponsor ID
- CR-0926
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson K.K. Medical Company, Visioncare Research Ltd.
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 1 Jun 2010 (actual)
- Study completion
- 1 Jun 2010 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 4 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etafilcon A/omafilcon A | Active comparator | Device: etafilcon A, Device: omafilcon Aetafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily |
| omafilcon A/etafilcon A | Active comparator | Device: etafilcon A, Device: omafilcon Aomafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- At least 18 years of age and no more than 39 years of age
- Existing soft contact lens wearers
- Willing to signed a written Informed Consent.
- Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
- Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
Key exclusion criteria (15 listed)
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Clinically significant corneal staining (Grade 3 in more than one region).
- Keratoconus or other corneal irregularity.
- Abnormal lachrymal secretions.
- Extended wear of contact lenses last 3 months.
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 A1-day soft contact lens | Device | etafilcon A/omafilcon A, omafilcon A/etafilcon A |
| omafilcon A1-day soft contact lens | Device | etafilcon A/omafilcon A, omafilcon A/etafilcon A |
Primary outcome
Subjective Rating of Comfort
Time frame: after 1 week of lens wear
This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Vision Quality
Time frame: after 1 week of lens wear
This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Subjective Rating of Handling
Time frame: after 1 week of lens wear
This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Corneal Staining
Time frame: after 1 week of lens wear
Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Subjective Rating of Quality Perceptions
Time frame: after 1 week of lens wear
This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Limbal Hyperemia
Time frame: after 1 week of wear
This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.
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.
Danny Sim, Diploma in Optometry principal investigator
Singapore Polytechnic
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 and omafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Singapore.
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 15 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 Singapore. 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 4 Oct 2011). 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?
Subjective Rating of Comfort (time frame: after 1 week of lens wear). The study lists 6 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.