AmetropiaNCT00639379
Comparison of Two Toric Contact Lenses on Current Toric Wearers
A study testing senofilcon A toric and alphafilcon A toric in people with Ametropia, run by Johnson & Johnson Vision Care, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ametropia
- What is being tested?
- senofilcon A toric and alphafilcon A toric
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2008to Jun 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 at least 18 and less than or equal to 45 years of age, have a need for vision correction and wear contact lenses in BOTH eyes (monovision or uni-ocular fitting is NOT allowed).
- Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.
- Be a currently successful wearer for at least 3 months of B\&L SofLens 66 Toric hydrogel lenses.
- Be able and willing to adhere to the instructions set forth in the protocol.
- 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.
- Have a distance spectacle spherical component between -1.00 D and -5.25 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 30° of the horizontal in both eyes (when the subject's prescription is presented in minus cylinder form).
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- Have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
- Be in good general health, based on his/her knowledge.
- Must be given an explanation of the study objectives, lens and solutions usage requirements and visit schedule. The subject must read, indicate understanding of and agree to begin participation in the clinical study. The subject must then sign the Informed Consent Form in the presence of the Investigator or their designee.
Who cannot join
- Presbyopic or has the need for a near add for reading.
- Previous refractive surgery; current or previous orthokeratology treatment.
- Aphakia, keratoconus or a highly irregular cornea.
- The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies).
- A known history of corneal hypoesthesia (reduced corneal sensitivity.)
- Anterior uveitis or iritis (past or present).
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- A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.
- Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.
- 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
- Neovascularization >1mm in from the limbus
- History of giant papillary conjunctivitis (GPC) worse than Grade 2
- Meibomian gland dysfunction, blepharitis, or seborrhoeic dermatitis
- Current pregnancy or lactation (to the best of the subject's knowledge).
- Actively participating in another clinical study at any time during this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Western Reserve Vision Care
Beachwood, Ohio, 44122
Primary Eyecare Group, P.C.
Brentwood, Tennessee, 37027
Southern Eyes
Concord, North Carolina, 28025
Ted Brink and Associates
Jacksonville, Florida, 32256
Clayton Eye Center
Morrow, Georgia, 30260
Eola Eyes
Orlando, Florida, 32801
The Koetting Associates Inc.
St Louis, Missouri, 63144
About this study
Official title: A Multi-Center, Subject Masked, Randomized, Two Week Crossover Design, Investigation of the Acuvue Cypress Toric Silicone Hydrogel Lens Compared to the Bausch & Lomb SofLens66® Toric Hydrophilic Lens
The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity
Read the detailed description
Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits:
Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense
- Conditions
- Ametropia
- Being tested
- senofilcon A toric, alphafilcon A toric
- Keywords
- toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings
- Medical subject headings
- Refractive Errors
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, 2 wk replacement, daily wear
alphafilcon A toricDevice
Also called SofLens Toric
hydrogel toric lens, 2 wk replacement, daily wear
| Study group | Role | What they receive |
|---|---|---|
| senofilcon A | Experimental | senofilcon A toric daily wear contact lenses Receives: Device: senofilcon A toric |
| alphafilcon A | Active comparator | alphafilcon A toric daily wear contact lenses Receives: Device: alphafilcon A toric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Orientation Within 5 Degrees
Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
Measured: 1 minute after insertion
Lens Stability
Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
Measured: 10-15 minutes after insertion
Subjective Lens Comfort
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, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.
Measured: 1 and 2 weeks
Subjective 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. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.
Measured: 1 and 2 weeks
Overall Corneal Staining
Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
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 posted20 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2008
- Study completionJun 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 AmetropiaStudies 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
- 89 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
- NCT00639379
- Sponsor's protocol ID
- CR-0802
- Status last verified
- May 2015
- First submitted
- 13 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
- A Multi-Center, Subject Masked, Randomized, Two Week Crossover Design, Investigation of the Acuvue Cypress Toric Silicone Hydrogel Lens Compared to the Bausch & Lomb SofLens66® Toric Hydrophilic Lens
- ClinicalTrials.gov ID
- NCT00639379
- Acronym / sponsor ID
- CR-0802
- Conditions
- Ametropia
- Keywords
- toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 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.
The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity
Detailed description
Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits:
Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| senofilcon A | Experimental | Device: senofilcon A toricsenofilcon A toric daily wear contact lenses |
| alphafilcon A | Active comparator | Device: alphafilcon A toricalphafilcon A toric daily wear contact lenses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be at least 18 and less than or equal to 45 years of age, have a need for vision correction and wear contact lenses in BOTH eyes (monovision or uni-ocular fitting is NOT allowed).
- Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.
- Be a currently successful wearer for at least 3 months of B\&L SofLens 66 Toric hydrogel lenses.
- Be able and willing to adhere to the instructions set forth in the protocol.
- 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.
Key exclusion criteria (16 listed)
- Presbyopic or has the need for a near add for reading.
- Previous refractive surgery; current or previous orthokeratology treatment.
- Aphakia, keratoconus or a highly irregular cornea.
- The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies).
- A known history of corneal hypoesthesia (reduced corneal sensitivity.)
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, 2 wk replacement, daily wear | Device | senofilcon A |
| alphafilcon A toricAlso: SofLens Torichydrogel toric lens, 2 wk replacement, daily wear | Device | alphafilcon A |
Primary outcome
Lens Orientation Within 5 Degrees
Time frame: 1 minute after insertion
Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
Lens Stability
Time frame: 10-15 minutes after insertion
Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
Subjective Lens Comfort
Time frame: 1 and 2 weeks
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, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.
Subjective Vision
Time frame: 1 and 2 weeks
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. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.
Overall Corneal Staining
Time frame: after 2 weeks use
Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 alphafilcon A toric in people with Ametropia, run by Johnson & Johnson Vision Care, Inc. at 7 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 9 inclusion and 16 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 7 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 Within 5 Degrees (time frame: 1 minute after insertion). The study lists 5 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.