AmetropiaNCT00597467
Study of Soft Contact Lens Use With 7 Day Extended Wear
A study testing VISA (comfilcon A) Silicone Hydrogel Soft contact lens and Acuvue 2 Soft Contact Lens in people with Ametropia, run by CooperVision, Inc. at 23 sites in United States.
Trial summary
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ametropia
- What is being tested?
- VISA (comfilcon A) Silicone Hydrogel Soft contact lens and Acuvue 2 Soft Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 23 sitesUnited States
- Study dates
- Mar 2006to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age as of the date of evaluation.
- Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes.
- Be correctable to visual acuities of at least 20/25 in each eye with spectacles.
- Be in good general health, based on his/her knowledge.
- Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- Possess wearable and visually functional eyeglasses.
Who cannot join
- Previously unsuccessful with contact lens wear.
- Rigid gas permeable contact lens wear within the past 12 months.
- Previous refractive surgery; current or previous orthokeratology treatment.
- Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment.
- Aphakia, keratoconus or an irregular cornea.
- A known history of corneal hypoesthesia
Show all 22Show fewer
- Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
- Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.
- Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- History of corneal ulcer, corneal infiltrates or fungal infections.
- Pterygium, pinguecula or corneal scars within the visual axis
- Pathological dry eye or associated findings (examples: Sjögren's syndrome, lupus erythematosus, sclerodermia)
- Neovascularization or ghost vessels > 1mm in from the limbus
- Seborrheic eczema, seborrheic conjunctivitis
- History of papillary conjunctivitis greater than Grade 2 (Mild)
- Anterior uveitis or iritis (past or present)
- Known sensitivity to the care systems used in this study.
- Poor personal hygiene
- Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.
- Any active participation in another clinical study within 30 days prior to this study.
- Subject is a member, relative or household member of the office staff, including the investigator(s).
- Subjects must read, indicate understanding of, and sign the Informed Consent Form.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
(Private Practice)
Andover, Massachusetts, 01810
Quinn Quinn & Associates
Athens, Ohio, 45701
Western Reserve Vision Care
Beachwood, Ohio, 44122
Primary Eyecare Group, P.C.
Brentwood, Tennessee, 37027
Ohio State University
Columbus, Ohio, 43210
Professional Eye Care Associates
Columbus, Ohio, 43215
Concord Ophthalmological Associates
Concord, New Hampshire, 03301
Vision Care Associates
East Lansing, Michigan, 48823
Twin Lakes Vision
Federal Way, Washington, 98023
Eye Care Associates, P.C.
Fort Collins, Colorado, 80521
(Private Practice)
Honolulu, Hawaii, 96814
Kato & Shoji Optometrists
Honolulu, Hawaii, 96815
La Mesa Vision Care Center
La Mesa, California, 91941
Snowy Range Vision Center
Laramie, Wyoming, 82070
Place Optical Company Inc
Le Roy, New York, 14482
Davis Eyecare Associates
Oak Lawn, Illinois, 60453
Eola Eyes
Orlando, Florida, 32801
(Private Practice)
Salt Lake City, Utah, 84106
(Private Practice)
San Diego, California, 92123
Drs. Cook, Reeder and Associates
San Diego, California, 92129
(Private Practice)
Santa Monica, California, 90403
The Koetting Associates Inc.
St Louis, Missouri, 63144
Eye Care Associates of Hawaii
Waipahu, Hawaii, 96797
About this study
Official title: An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.
Read the detailed description
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses in this open-labeled randomized study.
- Conditions
- Ametropia
- Being tested
- VISA (comfilcon A) Silicone Hydrogel Soft contact lens, Acuvue 2 Soft Contact Lens
- Keywords
- myopia, hyperopia, extended wear, ametropia
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISA (comfilcon A) Silicone Hydrogel Soft contact lensDevice
Also called Biofinity (comfilcon A)
Test device
Acuvue 2 Soft Contact LensDevice
Control device
| Study group | Role | What they receive |
|---|---|---|
| Test Contact Lenses | Experimental | VISA (comfilcon A) Silicone Hydrogel Soft contact lens Receives: Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens |
| Control Contact Lenses | Active comparator | Acuvue 2 Soft Contact Lens Receives: Device: Acuvue 2 Soft Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of serious and significant AEs
Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial
Measured: 1 Year
Secondary outcomes (1)
Contact Lens Visual Acuity
Contact lens visual acuity was assessed using LogMAR
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startMar 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Gleason, OD, Study director, FRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597467
- Sponsor's protocol ID
- CVI060105
- Status last verified
- Jul 2020
- First submitted
- 27 Dec 2007
- Last updated
- 17 Jul 2020
- Results posted
- No
- 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 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen
- ClinicalTrials.gov ID
- NCT00597467
- Acronym / sponsor ID
- CVI060105
- Conditions
- Ametropia
- Keywords
- myopia, hyperopia, extended wear, ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.
Detailed description
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses in this open-labeled randomized study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Contact Lenses | Experimental | Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lensVISA (comfilcon A) Silicone Hydrogel Soft contact lens |
| Control Contact Lenses | Active comparator | Device: Acuvue 2 Soft Contact LensAcuvue 2 Soft Contact Lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years of age as of the date of evaluation.
- Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes.
- Be correctable to visual acuities of at least 20/25 in each eye with spectacles.
- Be in good general health, based on his/her knowledge.
- Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
Key exclusion criteria (22 listed)
- Previously unsuccessful with contact lens wear.
- Rigid gas permeable contact lens wear within the past 12 months.
- Previous refractive surgery; current or previous orthokeratology treatment.
- Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment.
- Aphakia, keratoconus or an irregular cornea.
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 |
|---|---|---|
| VISA (comfilcon A) Silicone Hydrogel Soft contact lensAlso: Biofinity (comfilcon A)Test device | Device | Test Contact Lenses |
| Acuvue 2 Soft Contact LensControl device | Device | Control Contact Lenses |
Primary outcome
Frequency of serious and significant AEs
Time frame: 1 Year
Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial
1 secondary outcome
Contact Lens Visual Acuity
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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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.
William Gleason, OD study director
FRS
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VISA (comfilcon A) Silicone Hydrogel Soft contact lens and Acuvue 2 Soft Contact Lens in people with Ametropia, run by CooperVision, Inc. at 23 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 6 inclusion and 22 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of serious and significant AEs (time frame: 1 Year). 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 17 Jul 2020.