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
Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4 base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0 base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A and delefilcon A | Active Comparator | Participants randomized wear the stenfilcon A and the delefilcon A contralaterally. |
|
| stenfilcon A and narafilcon A | Active Comparator | Participants randomized wear the stenfilcon A and the narafilcon A contralaterally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Baseline |
| Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | 6 hours |
| Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Baseline |
| Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | 6 hours |
| Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Baseline |
| Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Is not a habitual wearer of soft spherical contact lenses
Has a contact lens prescription outside the range of the available parameters of the study lenses
Has a contact lens prescription outside the range of the inclusion power range
Has a spectacle cylinder ≥1.00D of cylinder in either eye
Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
Presence of clinically significant (grade > 2) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
Slit lamp findings that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea
Has Presbyopia or has dependence on spectacles for near work over the contact lenses
Has undergone corneal refractive surgery
Is participating in any other type of eye related clinical or research study
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Meng C Lin, OD PhD | CRC-UC Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, University of California, Berkeley | Berkeley | California | 94704 | United States |
Two participants enrolled in the study did not meet inclusion criteria. One participant was disqualified due to high power. All three participants therefore discontinued before lens randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A/Delefilcon A, Then Stenfilcon A/Narafilcon A | Participants randomized wear the stenfilcon A and delefilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and narafilcon A lens pair contralaterally. stenfilcon A: contact lens delefilcon A: contact lens narafilcon A: contact lens |
| FG001 | Stenfilcon A/Narafilcon A, Then Stenfilcon A/Delefilcon A | Participants randomized wear the stenfilcon A and narafilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and delefilcon A lens pair contralaterally. stenfilcon A: contact lens narafilcon A: contact lens delefilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
| |||||||||||||
| Second Intervention (1 Day) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participant Flow | Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally stenfilcon A: contact lens delefilcon A: contact lens narafilcon A: contact lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
Not provided
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 | Stenfilcon A | Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally stenfilcon A: contact lens delefilcon A: contact lens narafilcon A: contact lens |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taku Muraoka, OD, Director Professional Services Organization | Coopervision Japan | 81-3-5449-6619 | taku.muraoka@jp.coopervision.com |
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
| delefilcon A | Device | contact lens |
|
|
| narafilcon A | Device | contact lens |
|
|
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior |
| 6 hours |
| Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Baseline |
| Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | 6 hours |
| Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Baseline |
| Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | 6 hours |
| Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Baseline |
| Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | 6 hours |
| Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map) | 6 hours |
| Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map) | 6 hours |
| Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'. | Baseline |
| Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'. | 6 hours |
| Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal) | Baseline |
| Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal) | 6 hours |
| Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low) | Baseline |
| Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low) | 6 hours |
| Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose) | Baseline |
| Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose) | 6 hours |
| Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea) | Baseline |
| Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea) | 6 hours |
| Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)). | Baseline |
| Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)). | 6 hours |
| Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A |
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) |
| 6 hours |
| Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | Baseline |
| Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | 6 hours |
| Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | 6 hours |
| Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness). | Baseline, 3 hours, 6 hours |
| Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling). | Baseline, 3 hours, 6 hours |
| Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all). | Baseline and 6 hours |
| Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image). | Baseline, 3 hours, 6 hours |
| Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied). | 6 hours |
| Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred) | 6 hours |
| NOT COMPLETED |
|
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Stenfilcon A (Narafilcon A Group) | Participants randomized wear the stenfilcon A and the narafilcon A contralaterally stenfilcon A: contact lens narafilcon A: contact lens |
| OG003 | Narafilcon A | Participants randomized wear the stenfilcon A and the narafilcon A contralaterally. stenfilcon A: contact lens narafilcon A: contact lens |
|
|
| Primary | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
| Primary | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
| Primary | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
| Primary | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
| Primary | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
| Primary | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
| Primary | Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map) | Posted | Mean | Standard Deviation | mm | 6 hours |
|
|
|
| Primary | Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map) | Posted | Mean | Standard Deviation | microns | 6 hours |
|
|
|
| Primary | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'. | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'. | Posted | Number | participants | 6 hours |
|
|
|
| Primary | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal) | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal) | Posted | Number | participants | 6 hours |
|
|
|
| Primary | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low) | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low) | Posted | Number | participants | 6 hours |
|
|
|
| Primary | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose) | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose) | Posted | Number | participants | 6 hours |
|
|
|
| Primary | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea) | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea) | Posted | Number | participants | 6 hours |
|
|
|
| Primary | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)). | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)). | Posted | Number | participants | 6 hours |
|
|
|
| Secondary | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | Posted | Number | participants | 6 hours |
|
|
|
| Secondary | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | Posted | Number | participants | 6 hours |
|
|
|
| Secondary | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) | Posted | Number | participants | 6 hours |
|
|
|
| Secondary | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 hours, 6 hours |
|
|
|
| Secondary | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 hours, 6 hours |
|
|
|
| Secondary | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 hours |
|
|
|
| Secondary | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 hours, 6 hours |
|
|
|
| Secondary | Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied). | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
| Secondary | Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred) | Preference is missing for 1 participant in the stenfilcon A/delefilcon A group whom did not answer preference question of which lens is preferred. | Posted | Number | participants | 6 hours |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Delefilcon A | Participants randomized wear the stenfilcon A and the delefilcon A contralaterally stenfilcon A: contact lens delefilcon A: contact lens | 0 | 19 | 0 | 19 |
| EG002 | Narafilcon A | Participants randomized wear the stenfilcon A and the narafilcon A contralaterally stenfilcon A: contact lens narafilcon A: contact lens | 0 | 19 | 0 | 19 |
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
| T |
|
| S |
|
| I |
|
| T |
|
| S |
|
| I |
|
| T |
|
| S |
|
| I |
|
| T |
|
| S |
|
| I |
|
| T |
|
| S |
|
| I |
|
| N |
|
| T |
|
| S |
|
| I |
|
| N |
|
| T |
|
| S |
|
| I |
|
| N |
|
| T |
|
| S |
|
| I |
|
| N |
|
| T |
|
| S |
|
| I |
|
| N |
|
| T |
|
| S |
|
| I |
|
| N |
|
| T |
|
| S |
|
| I |
|
| No |
|
| No |
|
| Little temporal |
|
| Centered |
|
| Little loose |
|
| Loose |
|
| Little temporal |
|
| Centered |
|
| Little loose |
|
| Loose |
|
| Little Up |
|
| Centered |
|
| Little low |
|
| Low |
|
| Little Up |
|
| Centered |
|
| Little low |
|
| Low |
|
| Little tight |
|
| Optimal |
|
| Little loose |
|
| Loose |
|
| Little tight |
|
| Optimal |
|
| Little loose |
|
| Loose |
|
| Acceptable |
|
| No lag |
|
| Falls from cornea |
|
| Acceptable |
|
| No lag |
|
| Falls from cornea |
|
| Almost optimal |
|
| Border line to wear |
|
| Not acceptable (cannot wear) |
|
| Almost optimal |
|
| Border line to wear |
|
| Not acceptable (cannot wear) |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| 3 hours |
|
| 6 hours |
|
| 3 hours |
|
| 6 hours |
|
| 6 hours (removal) |
|
| 3 hours |
|
| 6 hours |
|