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This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.
This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A contact lens | Experimental | Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode |
|
| ocufilcon B contact lens | Active Comparator | Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A contact lens | Device | Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline visit and all follow-ups visits |
| 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). | Any occurrence from dispensing to month 3 visit |
| 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. | week 1 visit, week 2 visit, month 1 visit, month 2 visit combined |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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:
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:
To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.
To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Byrnes, OD | Principal Investigator | |
| Lee Rigel, OD | Principal Investigator | |
| Mary Jo Stiegemeier, OD | Principal Investigator | |
| Peter Van Hoven, OD | Principal Investigator | |
| Eric White, OD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eric M. White, OD, Inc. | San Diego | California | 92123 | United States | ||
| Vision Care Associates |
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A Contact Lens | Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode |
| FG001 | Ocufilcon B Contact Lens | Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stenfilcon A Contact Lens | Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode |
| BG001 | Ocufilcon B Contact Lens | Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings | Posted | Mean | Full Range | units on a scale | Change from baseline visit and all follow-ups visits | unique eyes | unique eyes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stenfilcon A Contact Lens | Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Papillary Conjunctivitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William J. Gleason, O.D. | Foresight Regulatory Strategies, Inc. | 978-658-6888 | 151 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ocufilcon B contact lens | Device | Daily disposable contact lens worn in a daily wear, daily disposable mode |
|
|
| Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 |
| 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. | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 |
| East Lansing |
| Michigan |
| 48823 |
| United States |
| Western Reserve Vision Care | Beachwood | Ohio | 44122 | United States |
| Primary Eyecare Group, P.C. | Brentwood | Tennessee | 37027 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
| OG001 | Ocufilcon B Contact Lens | Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode |
|
|
| 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). | Unique eyes are defined as each individual eye in the study. | Posted | Number | number of adverse events | Any occurrence from dispensing to month 3 visit | unique eyes | unique eyes |
|
|
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| 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). | Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms. | Posted | Number | percentage of eyes | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | unique eyes | unique eyes |
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| 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. | 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. | Posted | Number | percentage of possible examinations | week 1 visit, week 2 visit, month 1 visit, month 2 visit combined | possible examinations | possible examinations |
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| 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. | Posted | Mean | Standard Deviation | hours | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 |
|
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|
| 0 |
| 60 |
| 3 |
| 60 |
| EG001 | Ocufilcon B Contact Lens | Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode | 0 | 30 | 0 | 30 |
Release of this data (through presentation, publication or other written or oral communication) to other than listed personnel (listed in protocol) requires the prior written permission from the study Sponsor. Study investigators and all office personnel are prohibited from acknowledging participation in the study to individuals and organizations except those listed.
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