AmetropiaNCT02362724
Evaluation of Investigational (Frequent Replacement) FRP Lens for Daily Wear
A study testing Sapphire and Pearl in people with Ametropia, run by CooperVision, Inc. at 6 sites in United States.
Trial summary
The purpose of the study is to compare the investigational contact lens to a marketed contact lens. The study results were not used for design validation of investigational contact lens, Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ametropia
- What is being tested?
- Sapphire and Pearl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior to being considered eligible to participate in this study, each subject MUST:
- Be at least 18 years of age as of the date of evaluation for the study.
- Have:
- Read the Informed Consent
- been given an explanation of the Informed Consent
- indicated understanding of the Informed Consent
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- signed the Informed Consent document.
- Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
- Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
- Be in good general health, based on his/her knowledge.
- Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
- Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
- To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal.
Who cannot join
- Subjects may not be enrolled in this study if any of the following apply: The subject is currently or has:
- Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
- Poor personal hygiene.
- Any active participation in another clinical trial during this trial or within 30 days prior to this study.
- To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
- A member, relative or household member of the investigator or of the investigational office staff.
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- Has a known sensitivity to the ingredients used in the MPS approved for use in the study and is unable or unwilling to use the alternate care system.
- Previous refractive surgery; or current or previous orthokeratology treatment.
- Is aphakic or psuedophakic.
- Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
- The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
- The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
- A history of papillary conjunctivitis that has interfered with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2
- Pterygium
- Corneal scars within the visual axis
- Neovascularization or ghost vessels > 1.0 mm in from the limbus
- Giant papillary conjunctivitis (GPC) of > Grade 2
- Anterior uveitis or iritis
- Seborrheic eczema, seborrheic conjunctivitis or blepharitis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Premier Vision Services, LLC
Amarillo, Texas, 79119
Quinn Foster & Associates
Athens, Ohio, 45701
Primary Eyecare Group, P.C.
Brentwood, Tennessee, 37027
Advanced Family Eye Care
Denver, North Carolina, 28037
Eric M White OD, Inc.
San Diego, California, 92123
Office of Mark E Nakano, O.D.
Torrance, California, 90503
About this study
Official title: Evaluation of the CooperVision, Inc. Sapphire and Pearl Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear.
The purpose of the study is to compare the investigational contact lens to a marketed contact lens.
The study results were not used for design validation of investigational contact lens,
Read the detailed description
The objective of this evaluation is to provide evidence supporting the claim that the performance of the Test Lens is substantially equivalent to that of the Control Lens when used in a one month (up to 30 days) recommended replacement, daily wear modality.
The study results were not used for design validation of investigational contact lens,
- Conditions
- Ametropia
- Being tested
- Sapphire, Pearl
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SapphireDevice
silicone hydrogel contact lens
PearlDevice
silicone hydrogel contact lens
| Study group | Role | What they receive |
|---|---|---|
| Sapphire | Experimental | Subjects randomized to the experimental contact lens over the study duration Receives: Device: Sapphire |
| Pearl | Active comparator | Subjects randomized to the active comparator contact lens over the study duration Receives: Device: Pearl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit Lamp Findings for Epithelial Edema
Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: No microcysts; normal transparency, 1 TRACE: 1 to 20 microcysts; barely discernible local epithelial haziness, 2 MILD: 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 MODERATE: 51 to 100 microcysts; significant localized or generalized haziness, 4 SEVERE: >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Measured: Baseline (After lens dispensing)
Slit Lamp Findings for Epithelial Edema
Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: No microcysts; normal transparency, 1 TRACE: 1 to 20 microcysts; barely discernible local epithelial haziness, 2 MILD: 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 MODERATE: 51 to 100 microcysts; significant localized or generalized haziness, 4 SEVERE: >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Measured: 1 Month
Slit Lamp Findings for Stromal Edema
Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae)
Measured: Baseline (After lens dispensing)
Slit Lamp Findings for Stromal Edema
Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae)
Measured: 1 month
Slit Lamp Findings for Corneal Infiltrates
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Measured: Baseline (After lens dispensing)
Slit Lamp Findings for Corneal Infiltrates
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Measured: 1 Month
Slit Lamp Findings for Corneal Vascularization
Slit Lamp Findings for Corneal Vascularization on a grade 0-4 (0 NONE: No vessel penetration, 1 TRACE: <1.00 mm vessel penetration, 2 MILD: >1.00 mm to <1.50 mm vessel penetration, 3 MODERATE: >1.50 mm to <2.00 mm vessel penetration, 4 SEVERE: Vessel penetration >2.00 mm)
Measured: Baseline (After lens dispensing)
Slit Lamp Findings for Corneal Vascularization
Slit Lamp Findings for Corneal Vascularization on a grade 0-4 (0 NONE: No vessel penetration, 1 TRACE: <1.00 mm vessel penetration, 2 MILD: >1.00 mm to <1.50 mm vessel penetration, 3 MODERATE: >1.50 mm to <2.00 mm vessel penetration, 4 SEVERE: Vessel penetration >2.00 mm)
Measured: 1 month
Slit Lamp Findings for Limbal Hyperemia
Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)
Measured: Baseline (After lens dispensing)
Slit Lamp Findings for Limbal Hyperemia
Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)
Measured: 1 month
Slit Lamp Findings for Bulbar Hyperemia
Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)
Measured: Baseline (After lens dispensing)
Slit Lamp Findings for Bulbar Hyperemia
Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)
Measured: 1 month
Slit Lamp Findings for Palpebral Conjunctiva
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Measured: Baseline (After lens dispensing)
Slit Lamp Findings for Palpebral Conjunctiva
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Measured: 1 month
Slit Lamp Findings for Other Findings
Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)
Measured: Baseline (After lens dispensing)
Slit Lamp Findings for Other Findings
Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionDec 2015
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven L Saltzman, MD, FACOG, Study chair, Sterling IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362724
- Sponsor's protocol ID
- FC131202
- Status last verified
- Dec 2015
- First submitted
- 2 Feb 2015
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the CooperVision, Inc. Sapphire and Pearl Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear.
- ClinicalTrials.gov ID
- NCT02362724
- Acronym / sponsor ID
- FC131202
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Posted 24 Sep 2020
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 the study is to compare the investigational contact lens to a marketed contact lens.
The study results were not used for design validation of investigational contact lens,
Detailed description
The objective of this evaluation is to provide evidence supporting the claim that the performance of the Test Lens is substantially equivalent to that of the Control Lens when used in a one month (up to 30 days) recommended replacement, daily wear modality.
The study results were not used for design validation of investigational contact lens,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sapphire | Experimental | Device: SapphireSubjects randomized to the experimental contact lens over the study duration |
| Pearl | Active comparator | Device: PearlSubjects randomized to the active comparator contact lens over the study duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Prior to being considered eligible to participate in this study, each subject MUST:
Key exclusion criteria (22 listed)
- Subjects may not be enrolled in this study if any of the following apply: The subject is currently or has:
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 |
|---|---|---|
| Sapphiresilicone hydrogel contact lens | Device | Sapphire |
| Pearlsilicone hydrogel contact lens | Device | Pearl |
Primary outcome
Slit Lamp Findings for Epithelial Edema
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: No microcysts; normal transparency, 1 TRACE: 1 to 20 microcysts; barely discernible local epithelial haziness, 2 MILD: 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 MODERATE: 51 to 100 microcysts; significant localized or generalized haziness, 4 SEVERE: >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Slit Lamp Findings for Epithelial Edema
Time frame: 1 Month
Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: No microcysts; normal transparency, 1 TRACE: 1 to 20 microcysts; barely discernible local epithelial haziness, 2 MILD: 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 MODERATE: 51 to 100 microcysts; significant localized or generalized haziness, 4 SEVERE: >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Slit Lamp Findings for Stromal Edema
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae)
Slit Lamp Findings for Stromal Edema
Time frame: 1 month
Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae)
Slit Lamp Findings for Corneal Infiltrates
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Slit Lamp Findings for Corneal Infiltrates
Time frame: 1 Month
Slit Lamp Findings for Corneal Infiltrates - Present, Absent
Slit Lamp Findings for Corneal Vascularization
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Corneal Vascularization on a grade 0-4 (0 NONE: No vessel penetration, 1 TRACE: <1.00 mm vessel penetration, 2 MILD: >1.00 mm to <1.50 mm vessel penetration, 3 MODERATE: >1.50 mm to <2.00 mm vessel penetration, 4 SEVERE: Vessel penetration >2.00 mm)
Slit Lamp Findings for Corneal Vascularization
Time frame: 1 month
Slit Lamp Findings for Corneal Vascularization on a grade 0-4 (0 NONE: No vessel penetration, 1 TRACE: <1.00 mm vessel penetration, 2 MILD: >1.00 mm to <1.50 mm vessel penetration, 3 MODERATE: >1.50 mm to <2.00 mm vessel penetration, 4 SEVERE: Vessel penetration >2.00 mm)
Slit Lamp Findings for Limbal Hyperemia
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)
Slit Lamp Findings for Limbal Hyperemia
Time frame: 1 month
Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)
Slit Lamp Findings for Bulbar Hyperemia
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)
Slit Lamp Findings for Bulbar Hyperemia
Time frame: 1 month
Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia)
Slit Lamp Findings for Palpebral Conjunctiva
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Slit Lamp Findings for Palpebral Conjunctiva
Time frame: 1 month
Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent
Slit Lamp Findings for Other Findings
Time frame: Baseline (After lens dispensing)
Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE)
Slit Lamp Findings for Other Findings
Time frame: 1 month
Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (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 14 Oct 2020.
- 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.
Steven L Saltzman, MD, FACOG study chair
Sterling IRB
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sapphire and Pearl in people with Ametropia, run by CooperVision, Inc. at 6 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 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 24 Sep 2020). 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?
Slit Lamp Findings for Epithelial Edema (time frame: Baseline (After lens dispensing)). The study lists 16 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 14 Oct 2020.