Myopia
Conditions
Brief summary
The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.
Detailed description
The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.
Interventions
DEVICEomafilcon A
contact lens
DEVICEetafilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Is between 18 and 40 years of age (inclusive) * Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study. * Has had a self-reported visual exam in the last two years * Is an adapted soft CL (Contact Lens) wearer * Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so * Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive) * Has less than 0.75D (Diopters) spectacle cylinder in each eye. * Is correctable to a visual acuity of 20/25 or better in both eyes * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Is willing to comply with the wear schedule (at least 40 hrs per week) * Is willing to comply with the visit schedule
Exclusion criteria
A person will be excluded from the study if he/she: * Has never worn contact lenses before. * Currently wears rigid gas permeable contact lenses. * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has a CL prescription outside the range of - 1.00 to -6.00D * Has a spectacle cylinder greater than -0.50D of cylinder in either eye. * Has best corrected spectacle distance vision worse then 20/25 in either eye. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion * Has persistent, clinically significant corneal or conjunctival staining * Has active neovascularization or any central corneal scars. * Is aphakic. * Is presbyopic. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort (Subjective Assessment) | Baseline | Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel) |
| Hydration (Subjective Assessment) | Baseline | Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic) |
| Vision Quality (Subjective Assessment) | Baseline | Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp) |
| Vision Satisfaction (Subjective Assessment) | 1 Week | Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied) |
| Dryness (Subjective Assessment) | 1 Week | Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness) |
| Handling (Subjective Assessment) | 1 Week | Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy) |
| Eye Whiteness/Redness (Subjective Assessment) | 1 Week | Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white) |
| Overall Sensation of Smoothness (Subjective Assessment) | 1 Week | Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear? (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor) |
| Overall Satisfaction for Lens | 1 Week | Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall? (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Group Study participants are randomized to wear omafilcon A or etafilcon A pair of study lenses then crossover to the alternate pair. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (7 Days) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study Group |
|---|---|
| Age, Continuous | 28.1 years STANDARD_DEVIATION 5.03 |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Primary
Comfort (Subjective Assessment)
Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Time frame: 1 Week
Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Comfort (Subjective Assessment) | Insertion Comfort | 9.15 units on a scale | Standard Deviation 1.24 |
| Omafilcon A | Comfort (Subjective Assessment) | Comfort During Day | 8.12 units on a scale | Standard Deviation 2 |
| Omafilcon A | Comfort (Subjective Assessment) | Comfort Prior to Removal | 7.20 units on a scale | Standard Deviation 2.63 |
| Omafilcon A | Comfort (Subjective Assessment) | Comfort Overall | 7.84 units on a scale | Standard Deviation 1.75 |
| Etafilcon A | Comfort (Subjective Assessment) | Comfort Overall | 8.28 units on a scale | Standard Deviation 1.58 |
| Etafilcon A | Comfort (Subjective Assessment) | Insertion Comfort | 8.65 units on a scale | Standard Deviation 1.77 |
| Etafilcon A | Comfort (Subjective Assessment) | Comfort Prior to Removal | 7.70 units on a scale | Standard Deviation 1.95 |
| Etafilcon A | Comfort (Subjective Assessment) | Comfort During Day | 8.63 units on a scale | Standard Deviation 1.5 |
Primary
Comfort (Subjective Assessment)
Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Comfort (Subjective Assessment) | 9.12 units on a scale | Standard Deviation 1.17 |
| Etafilcon A | Comfort (Subjective Assessment) | 9.16 units on a scale | Standard Deviation 1.17 |
Primary
Dryness (Subjective Assessment)
Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)
Time frame: 1 Week
Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Dryness (Subjective Assessment) | Dryness During Day | 8.05 units on a scale | Standard Deviation 1.92 |
| Omafilcon A | Dryness (Subjective Assessment) | Dryness Prior to Removal | 7.24 units on a scale | Standard Deviation 2.43 |
| Omafilcon A | Dryness (Subjective Assessment) | Overall Dryness | 7.71 units on a scale | Standard Deviation 2.06 |
| Etafilcon A | Dryness (Subjective Assessment) | Dryness During Day | 8.58 units on a scale | Standard Deviation 1.48 |
| Etafilcon A | Dryness (Subjective Assessment) | Dryness Prior to Removal | 7.70 units on a scale | Standard Deviation 1.78 |
| Etafilcon A | Dryness (Subjective Assessment) | Overall Dryness | 8.14 units on a scale | Standard Deviation 1.71 |
Primary
Eye Whiteness/Redness (Subjective Assessment)
Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)
Time frame: 1 Week
Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Eye Whiteness/Redness (Subjective Assessment) | 8.63 units on a scale | Standard Deviation 1.65 |
| Etafilcon A | Eye Whiteness/Redness (Subjective Assessment) | 9.26 units on a scale | Standard Deviation 1.11 |
Primary
Handling (Subjective Assessment)
Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)
Time frame: 1 Week
Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Handling (Subjective Assessment) | Insertion and Removal | 8.85 units on a scale | Standard Deviation 1.99 |
| Omafilcon A | Handling (Subjective Assessment) | Overall | 8.85 units on a scale | Standard Deviation 1.99 |
| Etafilcon A | Handling (Subjective Assessment) | Insertion and Removal | 8.44 units on a scale | Standard Deviation 1.79 |
| Etafilcon A | Handling (Subjective Assessment) | Overall | 8.51 units on a scale | Standard Deviation 1.75 |
Primary
Hydration (Subjective Assessment)
Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Time frame: 1 Week
Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Hydration (Subjective Assessment) | Initial Hydration | 9.41 units on a scale | Standard Deviation 1 |
| Omafilcon A | Hydration (Subjective Assessment) | Hydration During Day | 8.02 units on a scale | Standard Deviation 1.88 |
| Omafilcon A | Hydration (Subjective Assessment) | Hydration Prior to Removal | 7.32 units on a scale | Standard Deviation 2.44 |
| Etafilcon A | Hydration (Subjective Assessment) | Initial Hydration | 8.84 units on a scale | Standard Deviation 1.41 |
| Etafilcon A | Hydration (Subjective Assessment) | Hydration During Day | 8.47 units on a scale | Standard Deviation 1.37 |
| Etafilcon A | Hydration (Subjective Assessment) | Hydration Prior to Removal | 7.53 units on a scale | Standard Deviation 1.91 |
Primary
Hydration (Subjective Assessment)
Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Hydration (Subjective Assessment) | 9.21 units on a scale | Standard Deviation 1.02 |
| Etafilcon A | Hydration (Subjective Assessment) | 9.35 units on a scale | Standard Deviation 1.09 |
Primary
Overall Satisfaction for Lens
Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall? (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)
Time frame: 1 Week
Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Overall Satisfaction for Lens | Completely Dissatisfied | 1 participants |
| Omafilcon A | Overall Satisfaction for Lens | Completely Satisfied | 17 participants |
| Omafilcon A | Overall Satisfaction for Lens | Somewhat Satisfied | 18 participants |
| Omafilcon A | Overall Satisfaction for Lens | Somewhat Dissatisfied | 5 participants |
| Etafilcon A | Overall Satisfaction for Lens | Somewhat Dissatisfied | 7 participants |
| Etafilcon A | Overall Satisfaction for Lens | Completely Dissatisfied | 1 participants |
| Etafilcon A | Overall Satisfaction for Lens | Somewhat Satisfied | 14 participants |
| Etafilcon A | Overall Satisfaction for Lens | Completely Satisfied | 21 participants |
Primary
Overall Sensation of Smoothness (Subjective Assessment)
Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear? (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)
Time frame: 1 Week
Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Good | 11 participants |
| Omafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Below Average | 3 participants |
| Omafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Average | 2 participants |
| Omafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Poor | 0 participants |
| Omafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Excellent | 25 participants |
| Etafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Poor | 0 participants |
| Etafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Excellent | 24 participants |
| Etafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Good | 7 participants |
| Etafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Average | 9 participants |
| Etafilcon A | Overall Sensation of Smoothness (Subjective Assessment) | Below Average | 3 participants |
Primary
Vision Quality (Subjective Assessment)
Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Vision Quality (Subjective Assessment) | 9.33 units on a scale | Standard Deviation 1.59 |
| Etafilcon A | Vision Quality (Subjective Assessment) | 9.16 units on a scale | Standard Deviation 1.79 |
Primary
Vision Satisfaction (Subjective Assessment)
Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)
Time frame: 1 Week
Population: One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Vision Satisfaction (Subjective Assessment) | 9.07 units on a scale | Standard Deviation 1.46 |
| Etafilcon A | Vision Satisfaction (Subjective Assessment) | 9.05 units on a scale | Standard Deviation 1.34 |