| Primary | Epithelial Edema - Fanfilcon A Lens (Test) | Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 | | | OG005 | Month 3 | | | OG006 | Unscheduled | |
| | Units | Counts |
|---|
| Participants | - OG00054
- OG00154
- OG00253
- OG003
|
| | Title | Denominators | Categories |
|---|
| None | | | Title | Measurements |
|---|
| - OG000100.0
- OG001100.0
- OG00299.1
- OG003
|
|
| |
| Primary | Epithelial Edema - Enfilcon A Lens (Control) | Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 | Month 2 |
|
| Primary | Stromal Edema - Fanfilcon A Lens (Test) | Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected during at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 | |
|
| Primary | Stromal Edema - Enfilcon A Lens (Control) | Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 | Month 2 |
|
| Primary | Corneal Infiltrates - Fanfilcon A Lens (Test) | Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 | |
|
| Primary | Corneal Infiltrates - Enfilcon A Lens (Control) | Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present | All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 | Month 2 |
|
| Primary | Corneal Vascularization - Fanfilcon A Lens (Test) | Corneal vascularization is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 | |
|
| Primary | Corneal Vascularization - Enfilcon A Lens (Control) | Corneal vascularization is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 | Month 2 |
|
| Primary | Corneal Staining - Fanfilcon A Lens (Test) | Corneal staining with fluorescein is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior; | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3 | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 |
|
| Primary | Corneal Staining - Enfilcon A Lens (Control) | Corneal staining with fluorescein is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior; | All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | |
|
| Primary | Limbal Hyperemia - Fanfilcon A Lens (Test) | Limbal hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 | |
|
| Primary | Limbal Hyperemia - Enfilcon A Lens (Control) | Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 | Month 2 |
|
| Primary | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Bulbar hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 | |
|
| Primary | Bulbar Hyperemia - Enfilcon A Lens (Control) | Bulbar hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 | Month 2 |
|
| Primary | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 | |
|
| Primary | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present | All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Number | | percentage of eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 | Month 2 |
|
| Primary | Visual Acuity - Fanfilcon A Lens (Test) | Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart. | All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. | Posted | | Number | | eyes | | Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Week 1 | | | OG001 | Week 2 | | | OG002 | Month 1 | | | OG003 | Month 2 | | | OG004 | Month 3 | |
| |
| Primary | Visual Acuity - Enfilcon A Lens (Control) | Visual acuity is assessed for enfilcon A lens (control) using Snellen chart. | All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. | Posted | | Number | | eyes | | Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Week 1 | enfilcon A lens (control) | | OG001 | Week 2 | enfilcon A lens (control) | | OG002 | Month 1 | enfilcon A lens (control) | | OG003 | Month 2 | enfilcon A lens (control) | | OG004 | Month 3 | enfilcon A lens (control) |
| |
| Primary | Average Wearing Time - Fanfilcon A Lens (Test) | Average lens wearing time for fanfilcon A lens (test) measured in hours. | All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Mean | Standard Deviation | hours | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 | |
|
| Primary | Average Wearing Time - Enfilcon A Lens (Control) | Average lens wearing time for enfilcon A lens (control) measured in hours. | All sites, control completed subjects' eyes. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Mean | Standard Deviation | hours | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 | Month 2 | |
|
| Secondary | Comfort - Fanfilcon A Lens (Test) | Fanfilcon A lens (test) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain). | All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Count of Units | | Eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | |
|
| Secondary | Comfort - Enfilcon A Lens (Control) | Enfilcon A lens (control) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain). | All sites, control completed subjects. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Count of Units | | eyes | | Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | |
|
| Secondary | Overall Vision Quality - Fanfilcon A Lens (Test) | Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable). | All sites, test subjects' completed. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Count of Units | | eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 |
|
| Secondary | Overall Vision Quality - Enfilcon A Lens (Control) | Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable). | All sites, control completed subjects. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Count of Units | | eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 |
|
| Secondary | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable. | All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3. | Posted | | Count of Units | | eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | | | OG001 | Week 1 | | | OG002 | Week 2 | | | OG003 | Month 1 | | | OG004 | Month 2 |
|
| Secondary | Ease of Insertion and Removal - Enfilcon A Lens (Control) | Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable. | All sites, control completed subjects' eyes. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3. | Posted | | Count of Units | | Eyes | | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Baseline | enfilcon A lens (control) | | OG001 | Week 1 | enfilcon A lens (control) | | OG002 | Week 2 | enfilcon A lens (control) | | OG003 | Month 1 | enfilcon A lens (control) | | OG004 |
|