Vision CorrectionNCT00638846
Performance of Two Silicone Hydrogel Toric Contact Lenses
A study testing senofilcon A toric and balafilcon A toric in people with Vision Correction, run by Johnson & Johnson Vision Care, Inc. at 19 sites in United States.
Trial summary
Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Correction
- What is being tested?
- senofilcon A toric and balafilcon A toric
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 19 sitesUnited States
- Study dates
- Feb 2008to May 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and 45 years of age.
- Sign Written Informed Consent (See separate document).
- Be an existing successful daily wear toric soft contact lens.
- Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
- Does not require presbyopic correction (can read J1 @ normal reading distance).
- Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
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- Have refractive astigmatism between 0.75D and 2.50D in both eyes.
- Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia.
- No evidence of lid abnormality or infection.
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. stromal edema, vascularisation, infiltrates or abnormal opacities).
- No other active ocular disease.
Who cannot join
- Requires concurrent ocular medication.
- Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Corneal staining Grade 3 in more than one region.
- Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
- Abnormal lacrimal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
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- Keratoconus or other corneal irregularity.
- Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks
- Extended lens wear in last 3 months.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Diabetic.
- Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or in last 60 days.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
The Eye & Contact Lens Clinic
Bremerton, Washington, 98310
Dr. Larry Menning
Chamberlain, South Dakota, 57325-0490
Executive Park Eye Care
Colorado Springs, Colorado, 80909
Dr. James Brobst
Florence, New Jersey, 08518
Matus Eyecare
Franklin, Wisconsin, 53132
Dr. Ted Brink and Associates
Jacksonville, Florida, 32256
Wishnow-Sugar Vision Group
Katy, Texas, 77450
Selden Eyecare LLC
Kittanning, Pennsylvania, 16201
Midlothian Optometric Center
Midlothian, Virginia, 23113
James R. Dugue, O.D.
Mission Viejo, California, 92691
Grene Vision Group
Neodesha, Kansas, 66757
Camp Eye Care Clinic
North Little Rock, Arkansas, 72116
Advanced Eyecare, PC
Raytown, Missouri, 64133
Fine Eye Care Associates
Rochester, New York, 14623
Dr. William Bogus
Salt Lake City, Utah, 84106
Nittany Eye Associates
State College, Pennsylvania, 16801
The Eye Specialists, Ltd.
Virginia Beach, Virginia, 23455
Warren Ophthalmology Associates
Warren, Ohio, 44484
Dr. David W. Ferris and Associates
Warwick, Rhode Island, 02886
About this study
Official title: Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses
Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.
- Conditions
- Vision Correction
- Being tested
- senofilcon A toric, balafilcon A toric
- Keywords
- toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon A toricDevice
Also called ACUVUE OASYS
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
balafilcon A toricDevice
Also called PureVision Toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
| Study group | Role | What they receive |
|---|---|---|
| senofilcon A toric | Experimental | senofilcon A, daily wear, toric contact lens worn for two weeks Receives: Device: senofilcon A toric |
| balafilcon A toric | Active comparator | balafilcon A, daily wear, toric contact lens worn for two weeks Receives: Device: balafilcon A toric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Orientation
Proportion of eyes with lens orientation within 5 degrees of optimal
Measured: 1 minute after insertion
Lens Stability
Lens stability is measured as the amount of rotation induced from blink after the lens has settled.
Measured: 10-15 minutes after insertion
Subjective Comfort
Subjective comfort was derived from 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. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.
Measured: 2 weeks of lens wear
Secondary outcomes (3)
Time to Fit Lens
Time required for the optometrist to fit the lens.
Measured: after lens insertion
Subjective Lens Vision
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 was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.
Measured: measured at 1 and 2 weeks
Overall Corneal Staining
National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.
Measured: After 2 weeks use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
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 Vision CorrectionStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graeme YOung, MPhil PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638846
- Sponsor's protocol ID
- CR-0801
- Other IDs
- CTOR-501
- Status last verified
- May 2015
- First submitted
- 10 Mar 2008
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT00638846
- Acronym / sponsor ID
- CR-0801
- Conditions
- Vision Correction
- Keywords
- toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Posted 19 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| senofilcon A toric | Experimental | Device: senofilcon A toricsenofilcon A, daily wear, toric contact lens worn for two weeks |
| balafilcon A toric | Active comparator | Device: balafilcon A toricbalafilcon A, daily wear, toric contact lens worn for two weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Be between 18 and 45 years of age.
- Sign Written Informed Consent (See separate document).
- Be an existing successful daily wear toric soft contact lens.
- Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
- Does not require presbyopic correction (can read J1 @ normal reading distance).
Key exclusion criteria (14 listed)
- Requires concurrent ocular medication.
- Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Corneal staining Grade 3 in more than one region.
- Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
- Abnormal lacrimal secretions.
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 |
|---|---|---|
| senofilcon A toricAlso: ACUVUE OASYSsilicone hydrogel toric lens, worn daily for 2 wks (2wks replacement) | Device | senofilcon A toric |
| balafilcon A toricAlso: PureVision Toricsilicone hydrogel toric lens, worn daily for 2 wks (2wks replacement) | Device | balafilcon A toric |
Primary outcome
Lens Orientation
Time frame: 1 minute after insertion
Proportion of eyes with lens orientation within 5 degrees of optimal
Lens Stability
Time frame: 10-15 minutes after insertion
Lens stability is measured as the amount of rotation induced from blink after the lens has settled.
Subjective Comfort
Time frame: 2 weeks of lens wear
Subjective comfort was derived from 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. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.
3 secondary outcomes
Time to Fit Lens
Time frame: after lens insertion
Subjective Lens Vision
Time frame: measured at 1 and 2 weeks
Overall Corneal Staining
Time frame: After 2 weeks use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- 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.
Graeme YOung, MPhil PhD study director
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon A toric and balafilcon A toric in people with Vision Correction, run by Johnson & Johnson Vision Care, Inc. at 19 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 14 inclusion and 14 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 19 Jul 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 Orientation (time frame: 1 minute after insertion). 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 21 May 2015.