Myopia
Conditions
Keywords
silicone hydrogel contact lens, SHCL, stenfilcon A, ocufilcon B, daily disposable, substantial equivalence, CooperVision ClearSight™ 1 Day SCL
Brief summary
This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.
Detailed description
This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.
Interventions
Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
DEVICEocufilcon B contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 * 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 on a daily basis for at least 8 hours per day for at least one month prior to participation in the study. * Possess wearable and visually functional eyeglasses. * Be in good general health, based on his/her knowledge. * Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 1.00 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. * Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.
Exclusion criteria
Subjects may not be enrolled in this study if any of the following apply: The subject is/has: * Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. 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 within 30 days prior to this study. * Currently pregnant (to the best of the subject's knowledge), 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. * Has a known sensitivity to ingredients used in the over the counter contact lens lubricants approved for use in the study. * 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, sclerodermia, keratoconus or type II diabetes. * The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day. * 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. * A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates 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 To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Assessment: Ocular Response - Biomicroscopy | Change from baseline visit and all follow-ups visits | The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared. |
| Comparison of Objective Findings - Number of Adverse Events in Unique Eyes | Any occurrence from dispensing to month 3 visit | The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit). |
| Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better | week 1 visit, week 2 visit, month 1 visit, month 2 visit combined | The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B. Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens. Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3). |
| Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3. |
Countries
United States
Participant flow
Pre-assignment details
Ninety-three subjects evaluated, 3 subjects found to be ineligible and not randomized or dispensed. 90 adapted single-vision contact lens wearers with myopia were randomized and dispensed on a 2 to 1 ratio within each site and across entire study. Subjects used that same assigned product throughout study duration
Participants by arm
| Arm | Count |
|---|---|
| Stenfilcon A Contact Lens Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode | 60 |
| Ocufilcon B Contact Lens Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Ocufilcon B Contact Lens | Stenfilcon A Contact Lens | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 60 Participants | 90 Participants |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 8.55 | 32.6 years STANDARD_DEVIATION 8.884 | 31.7 years STANDARD_DEVIATION 8.822 |
| Region of Enrollment United States | 30 participants | 60 participants | 90 participants |
| Sex: Female, Male Female | 21 Participants | 38 Participants | 59 Participants |
| Sex: Female, Male Male | 9 Participants | 22 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 60 | 0 / 30 |
| serious Total, serious adverse events | 0 / 60 | 0 / 30 |
Outcome results
Primary
Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B. Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.
Time frame: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined
Population: For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stenfilcon A Contact Lens | Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better | 99.3 percentage of possible examinations |
| Ocufilcon B Contact Lens | Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better | 100 percentage of possible examinations |
Primary
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).
Time frame: Any occurrence from dispensing to month 3 visit
Population: Unique eyes are defined as each individual eye in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stenfilcon A Contact Lens | Comparison of Objective Findings - Number of Adverse Events in Unique Eyes | 7 number of adverse events |
| Ocufilcon B Contact Lens | Comparison of Objective Findings - Number of Adverse Events in Unique Eyes | 1 number of adverse events |
Primary
Objective Assessment: Ocular Response - Biomicroscopy
The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.
Time frame: Change from baseline visit and all follow-ups visits
Population: Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, Baseline | 1.00 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, All Follow-up | 1.00 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, Baseline | 1.00 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, All Follow-up | 1.09 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, Baseline | 1.00 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, All Follow-up | 1.03 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, Baseline | 1.00 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, All Follow-up | 1.05 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Palperbral Conjunctiva, Baseline | 1.10 units on a scale |
| Stenfilcon A Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Palpebral Conjunctiva, All Follow-up | 1.38 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, All Follow-up | 1.02 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, Baseline | 1.00 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, All Follow-up | 1.05 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, All Follow-up | 1.10 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Palpebral Conjunctiva, All Follow-up | 1.00 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, Baseline | 1.00 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, Baseline | 1.00 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, All Follow-up | 1.18 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Palperbral Conjunctiva, Baseline | 1.00 units on a scale |
| Ocufilcon B Contact Lens | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, Baseline | 1.00 units on a scale |
Secondary
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn
The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Baseline | 15.04 hours | Standard Deviation 3.846 |
| Stenfilcon A Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Week 1 | 13.71 hours | Standard Deviation 2.281 |
| Stenfilcon A Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Week 2 | 13.69 hours | Standard Deviation 2.235 |
| Stenfilcon A Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Month 1 | 13.67 hours | Standard Deviation 2.52 |
| Stenfilcon A Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Month 2 | 13.81 hours | Standard Deviation 2.774 |
| Stenfilcon A Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Month 3 | 14.00 hours | Standard Deviation 2.44 |
| Ocufilcon B Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Month 2 | 13.41 hours | Standard Deviation 2.693 |
| Ocufilcon B Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Baseline | 13.74 hours | Standard Deviation 4.182 |
| Ocufilcon B Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Month 1 | 12.81 hours | Standard Deviation 2.64 |
| Ocufilcon B Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Week 1 | 13.18 hours | Standard Deviation 2.539 |
| Ocufilcon B Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Month 3 | 13.28 hours | Standard Deviation 2.576 |
| Ocufilcon B Contact Lens | Evaluation of Average Lens Wearing Time - Average Daily Hours Worn | Week 2 | 13.31 hours | Standard Deviation 2.523 |
Secondary
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort
The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens. Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3).
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Baseline | 73.6 percentage of eyes |
| Stenfilcon A Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Week 1 | 43.9 percentage of eyes |
| Stenfilcon A Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Week 2 | 60.9 percentage of eyes |
| Stenfilcon A Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Month 1 | 55.4 percentage of eyes |
| Stenfilcon A Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Month 2 | 59.6 percentage of eyes |
| Stenfilcon A Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Month 3 | 55.3 percentage of eyes |
| Ocufilcon B Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Month 2 | 55.2 percentage of eyes |
| Ocufilcon B Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Baseline | 70.4 percentage of eyes |
| Ocufilcon B Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Month 1 | 60.3 percentage of eyes |
| Ocufilcon B Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Week 1 | 50.0 percentage of eyes |
| Ocufilcon B Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Month 3 | 58.6 percentage of eyes |
| Ocufilcon B Contact Lens | Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort | Week 2 | 55.2 percentage of eyes |