Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Waterloo | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.
Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Habitual no Replacement, then Habitual Replacement | Other | Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a replacement pair dispensed at Day 28. |
|
| Phase 1: Habitual Replacement, then Habitual no Replacement | Other | Contact lenses per participant's habitual prescription worn for 30 days with replacement pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement. |
|
| Phase 2: Lotrafilcon B Replacement | Other | Contact lenses worn for 56 days with replacement pair dispensed at Day 28. |
|
| Phase 3: Lotrafilcon B Replacement Replacement | Other | Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Habitual contact lens | Device | Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | Day 1 |
| Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | Day 1 |
| Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | Day 1 |
| Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | Day 15 |
| Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Desmond Fonn, MOptom FAAO | University of Waterloo Centre for Contact Lens Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
Baseline characteristics are presented for all enrolled participants: 78. The participant flow chart includes all enrolled and dispensed participants: 72. Six participants were enrolled but not dispensed.
Participants were recruited from one Canadian research center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Habitual no Replacement, Then Habitual Replacement | Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a new pair dispensed at Day 28. |
| FG001 | Phase 1: Habitual Replacement, Then Habitual no Replacement | Contact lenses per participant's habitual prescription worn for 30 days with a new pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement. |
| FG002 | Phase 2: Lotrafilcon B Replacement | Contact lenses worn for 56 days with replacement pair dispensed at Day 28. |
| FG003 | Phase 3: Lotrafilcon B Replacement Replacement | Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Period One, 30 Days of Wear |
|
| ||||||||||||||||||
| Phase 1: Period Two, 30 Days of Wear |
| |||||||||||||||||||
| Phase 2: 56 Days of Wear |
| |||||||||||||||||||
| Phase 3: 43 Days of Wear |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This reporting group includes all enrolled and dispensed participants. |
| 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 | Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 |
|
Adverse events were collected for the duration of the study: 8-JUL-2010 to 19-JUL-2011.
The safety population includes all enrolled and dispensed participants.
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 | Habitual Contact Lens | Contact lens per participant's habitual prescription worn for two 30-day periods in Phase 1, with a replacement dispensed at Day 28 in either Period 1 or Period 2. |
Not provided
Not provided
The current study design and sample size was not able to uncover clinically meaningful differences between survivors and strugglers. There is considerable individual variation in lens performance with age, which requires further investigation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. Alan Landers, O.D., M.S., F.A.A.O. | Alcon Research | 1-800-241-7629 |
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lotrafilcon B contact lens | Device | Commercially marketed silicone hydrogel contact lens |
|
|
| Contact lens cleaning and disinfecting system (ClearCare) | Device | Commercially marketed, hydrogen peroxide-based contact lens care system |
|
|
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")
| Day 15 |
| Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | Day 15 |
| Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | Day 43 |
| Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | Day 43 |
| Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | Day 43 |
| Asymptomatic infiltrates |
|
| Unable to achieve acceptable comfort |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Strugglers: Lotrafilcon B/Replacement/Replacement | Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2. |
|
|
| Primary | Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 |
|
|
|
| Primary | Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 |
|
|
|
| Primary | Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 15 |
|
|
|
| Primary | Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 15 |
|
|
|
| Primary | Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 15 |
|
|
|
| Primary | Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 43 |
|
|
|
| Primary | Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 43 |
|
|
|
| Primary | Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.") | All enrolled and dispensed participants, Phase 3. | Posted | Mean | Standard Deviation | Units on a scale | Day 43 |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Lotrafilcon B Contact Lens | Contact lens worn for 56 days with a replacement dispensed at Day 28 in Phase 2, followed by 43 days in Phase 3 with a replacement dispensed at Day 1 and Day 14. | 0 | 67 | 0 | 67 |
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.