Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this investigation is to compare the visual clinical performance of two daily disposable soft contact lenses.
This is a prospective, multiple day, double (investigator and subject) masked, randomized, bilateral crossover study comparing a Test lens against an appropriate Control lens. Main aim is to compare visual acuity and subjective vision ratings of vision quality between two lenses in habitual soft lens wearers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lenses, Then Control Lenses | Experimental | Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week. |
|
| Control Lenses, Then Test Lenses | Experimental | Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Lenses (stenfilcon A) | Device | Daily disposable, soft contact lenses worn for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| High Contrast, Binocular, Distance Visual Acuity (logMAR) | High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit. | At the end of one week wear |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Vision Quality | Subjective vision quality on 0-100 Visual Analog Scale (where, 0=very poor and 100=very good) | At the end of one week wear |
Not provided
Inclusion Criteria:
Are 8 to 18 years of age (inclusively)
Have read, signed and dated:
Are willing and able to follow instructions and maintain the appointment schedule.
Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye, including myopia control soft contact lenses as below-
Currently wears spherical soft contact lenses or myopia control soft contact lenses.
Have a pair of wearable back-up spectacles.
Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study.
Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D
Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction.
Have clear corneas with no corneal scars or any active ocular disease.
Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit.
Demonstrate an acceptable fit with the study contact lenses.
Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pete S Kollbaum, OD, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab (CORL) | Bloomington | Indiana | 47405 | United States |
Ten participants were enrolled in the study. One participant was excluded due to screening failure. (n=9)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test Lenses First, Then Control Lenses | Participants wore the Test Lenses in both eyes for one week and then crossed over to the Control Lenses in both eyes for one week. |
| FG001 | Control Lenses First, Then Test Lenses | Participants wore the Control Lenses in both eyes for one week and then crossed over to the Test Lenses in both eyes for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (Period 1): First Intervention (7 Days) |
| |||||||||||||
| (Period 2): Second Intervention (7 Days) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total eight participants were analyzed who completed all study visits. (One participant was excluded from the analysis due to protocol deviation) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | High Contrast, Binocular, Distance Visual Acuity (logMAR) | High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit. | Analysis population includes all the participants who completed all the study visits. | Posted | Mean | Standard Deviation | logMAR | At the end of one week wear |
|
Duration study, approximately 20 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Lenses (Stenfilcon A) | All participants that received the Test Lenses | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Conjuctivitis | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Hall | CooperVision | +19256604365 | LHall@coopervision.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2022 | Jul 29, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Lenses (omafilcon A) | Device | Daily disposable, soft contact lenses worn for one week. |
|
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Subjective Vision Quality | Subjective vision quality on 0-100 Visual Analog Scale (where, 0=very poor and 100=very good) | Posted | Mean | Standard Deviation | units on a scale | At the end of one week wear |
|
|
|
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Control Lenses (Omafilcon A) | All participants that received the Control Lenses | 0 | 9 | 0 | 9 | 1 | 9 |
| Lightheaded | General disorders | Systematic Assessment |
|
Not provided