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
Not provided
Not provided
Not provided
Not provided
This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens followed by the Control Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods. |
|
| Control/Test | Experimental | Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens followed by the Test Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent. | Device | Test Lens |
| Measure | Description | Time Frame |
|---|---|---|
| Distance (4m) Monocular High Luminance High Contrast (HLHC) logMAR Visual Acuity (VA) | VA will be assessed monocularly under HLHC conditions at a test distance of 4 meters using ETDRS Charts. | At each 1-week follow-up per wear period |
| Toric Lens Orientation | Toric lens orientation (scribe mark position relative to 6 o'clock) will be assessed for each eye at 15 minutes after lens insertion. Toric lens orientation will be used to define a binary endpoint, i.e. the percentage of eyes that achieve absolute toric lens rotation ≤ 10°. | At baseline per wear period |
| Lens Rotational Stability with Blinks | Rotational stability will be assessed for each eye at least 15 minutes after lens insertion. Lens rotational stability with blinks will be defined as a binary endpoint, the percentage of eyes that achieve rotational stability with blinks ≤ 5°. | At baseline per wear period |
| Percentage of eyes with Grade 3 or higher SLFs relating to the test lens | SLFs (Grade 3 or higher) related to study lens wear for the test lens will be assessed for each eye at all study visits (scheduled and unscheduled). SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings. The percentage of eyes with Grade 3 or higher SLF will be analyzed and will include corneal infiltrates. | Up to 3-week follow-up |
| Percentage of eyes with acceptable lens fitting while wearing the test lens | Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye and used to define a binary endpoint, i.e. the percentage of eyes that achieve acceptable lens fit while wearing the test lens. Lens fit will be deemed unacceptable if any one of the following criteria are met:
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Comfort | Subjective overall Comfort scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. |
Not provided
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week during last 30 days.
Possess a wearable pair of spectacles that provide correction for distance vision.
In both eyes, have astigmatic refractive error suitable for correction with the toric contact lens powers available in this study:
Have best corrected monocular distance visual acuity of 20/30 or better in each eye.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James R. Dugue, Optometrist | Mission Viejo | California | 92691 | United States | ||
| Scripps Poway Eyecare & Optometry |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent. | Device | Control Lens |
|
| Up to 3-week follow-up |
| At each 1-week follow-up per wear period |
| Subjective Overall Quality of Vision | Subjective Overall Quality of Vision scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | At each 1-week follow-up per wear period |
| Subjective Overall Handling | Subjective Overall Handling scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | At each 1-week follow-up per wear period |
| San Diego |
| California |
| 92131 |
| United States |
| Stam & Associates Eye Care | Jacksonville | Florida | 32256 | United States |
| Pearson Research Center PA | Longwood | Florida | 32779 | United States |
| Maitland Vision Centers - North Orlando Ave | Maitland | Florida | 32751 | United States |
| Mid-State Eye | Clinton | Illinois | 61727 | United States |
| Franklin Park Eye Center, P.C. | Franklin Park | Illinois | 60131 | United States |
| Kannarr Eye Care - 101 North Broadway | Pittsburg | Kansas | 66762 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Advanced Eyecare - Raytown, MO | Raytown | Missouri | 64133 | United States |
| The Koetting Associates | St Louis | Missouri | 63144 | United States |
| ABQ Eye Care | Albuquerque | New Mexico | 87109 | United States |
| Spectrum Eye Care | Jamestown | New York | 14750 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Professional Vision Care Inc. - Westerville | Westerville | Ohio | 43081 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| Clarke EyeCare Center | Wichita Falls | Texas | 76308 | United States |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided