Refractive ErrorNCT00762385
Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
A study testing galyfilcon A and comfilcon A in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc..
Trial summary
The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Refractive Error
- What is being tested?
- galyfilcon A and comfilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Oct 2007
- 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 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
- The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
- The subject, based on his/her knowledge, must be in good general health.
- The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
- Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
- Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
- Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
- The subject must read, indicate understanding of and sign the Informed Consent Form.
Who cannot join
- The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
- The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
- Slit lamp findings that would contraindicate contact lens wear such as:
- pathological dry eye or associated findings
- pterygium or corneal scars within the visual axis
Show all 17Show fewer
- neovascularization equal to or greater than 1mm in from the limbus
- history of giant papillary conjunctivitis (GPC) worse than grade 2
- anterior uveitis or iritis (past or present)
- seborrhoeic eczema
- seborrhoeic conjunctivitis
- A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
- A known history of corneal hypoesthesia (reduced corneal sensitivity).
- Contact lens snellen visual acuities (VA) worse than 20/30.
- Aphakia, keratoconus or a highly irregular cornea.
- Current pregnancy or lactation (to the best of the subject's knowledge)
- Any active participation in another clinical study at any time during this study.
About this study
The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.
- Conditions
- Refractive Error
- Being tested
- galyfilcon A, comfilcon A
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galyfilcon ADevice
galyfilcon A
comfilcon ADevice
comfilcon A
| Study group | Role | What they receive |
|---|---|---|
| galyfilcon A/comfilcon A | Active comparator | galyfilcon A first, comfilcon A second Receives: Device: galyfilcon A; Device: comfilcon A |
| comfilcon A/galyfilcon A | Active comparator | comfilcon A first, galyfilcon A second Receives: Device: galyfilcon A; Device: comfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Comfort
>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.
Measured: 1-week, 2- weeks
Comfort Symptoms
A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable
Measured: 1-week, 2-weeks
Secondary outcomes (1)
Overall Corneal Staining
Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startAug 2007
- Primary completionOct 2007
- Study completionOct 2007
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 Refractive ErrorStudies 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foresight Regulatory Strategies, Inc., Visioncare Research Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762385
- Sponsor's protocol ID
- CR-0713
- Status last verified
- May 2015
- First submitted
- 29 Sep 2008
- 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 Comparison of Two Silicone-Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT00762385
- Acronym / sponsor ID
- CR-0713
- Conditions
- Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Foresight Regulatory Strategies, Inc., Visioncare Research Ltd.
- Study start
- Aug 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 10 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| galyfilcon A/comfilcon A | Active comparator | Device: galyfilcon A, Device: comfilcon Agalyfilcon A first, comfilcon A second |
| comfilcon A/galyfilcon A | Active comparator | Device: galyfilcon A, Device: comfilcon Acomfilcon A first, galyfilcon A second |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
- The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
- The subject, based on his/her knowledge, must be in good general health.
- The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
- Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
Key exclusion criteria (17 listed)
- The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
- The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
- Slit lamp findings that would contraindicate contact lens wear such as:
- A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
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 Agalyfilcon A | Device | comfilcon A/galyfilcon A, galyfilcon A/comfilcon A |
| comfilcon Acomfilcon A | Device | comfilcon A/galyfilcon A, galyfilcon A/comfilcon A |
Primary outcome
Lens Comfort
Time frame: 1-week, 2- weeks
>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.
Comfort Symptoms
Time frame: 1-week, 2-weeks
A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable
1 secondary outcome
Overall Corneal Staining
Time frame: 2 weeks
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.
Questions about this trial
What is this clinical trial studying?
A study testing galyfilcon A and comfilcon A in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc..
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 8 inclusion and 17 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.
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 10 Feb 2010). 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?
Lens Comfort (time frame: 1-week, 2- weeks). 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.