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The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReNu MultiPlus | Active Comparator | ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. |
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| Complete Easy Rub | Active Comparator | Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. |
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| Clear Care | Active Comparator | Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete Easy Rub | Device | Commercially marketed contact lens solution for contact lens care |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Circumlimbal Conjunctival Staining Score | Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week | Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve. | Dispense (Day 0), 1 week |
| Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Ramsey, O.D. | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 1 week before switching to the next assigned product. A 36-hour washout preceded each usage period.
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| ID | Title | Description |
|---|---|---|
| FG000 | ReNu / Complete / Clear Care | ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each |
| FG001 | Complete / Clear Care / ReNu | Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each |
| FG002 | Clear Care / ReNu / Complete | Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each |
| FG003 | ReNu / Clear Care / Complete | ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each |
| FG004 | Complete / ReNu / Clear Care | Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each |
| FG005 | Clear Care / Complete / ReNu | Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Week of Wear |
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| Second Week of Wear |
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| Third Week of Wear |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Baseline characteristics are presented for all participants completing all three treatment sequences. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean Circumlimbal Conjunctival Staining Score | Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome. | This reporting group includes all participants who completed all study visits. | Posted | Mean | Standard Deviation | Units on a scale | 1 week |
|
Adverse events were collected for the duration of the study.
This reporting group includes all enrolled and exposed participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ReNu MultiPlus | ReNu MultiPlus used for one week as specified in the protocol with study contact lenses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Unrelated to study procedures or study products |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Alcon Clinical | Alcon Research, Ltd. | 1-888-451-3937 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| ReNu MultiPlus | Device | Commercially marketed contact lens solution for contact lens care |
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| Clear Care | Device | Commercially marketed contact lens solution for contact lens care |
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| Contact lenses | Device | Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week. |
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Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter. |
| Dispense (Day 0), 1 week |
| Adverse Event |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
| OG001 | Complete Easy Rub | Complete Easy Rub used for one week as specified in the protocol with study contact lenses. |
| OG002 | Clear Care | Clear Care used for one week as specified in the protocol with study contact lenses. |
|
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| Secondary | Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week | Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve. | This reporting group includes all participants who completed all study visits. | Posted | Mean | Standard Deviation | mm | Dispense (Day 0), 1 week |
|
|
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| Secondary | Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week | Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter. | This reporting group includes all participants who completed all study visits. | Posted | Mean | Standard Deviation | mm | Dispense (Day 0), 1 week |
|
|
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| 1 |
| 22 |
| 0 |
| 22 |
| EG001 | Complete Easy Rub | Complete Easy Rub used for one week as specified in the protocol with study contact lenses. | 0 | 22 | 0 | 22 |
| EG002 | Clear Care | Clear Care used for one week as specified in the protocol with study contact lenses. | 0 | 22 | 0 | 22 |
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