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The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 114576A / renu fresh | Other | FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days. |
|
| renu fresh / FID 114675A | Other | Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 114675A multi-purpose disinfecting solution (MPDS) | Device | Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit | As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements. | Day 14 of lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score | The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects were recruited from 5 US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | FID 114576A / Renu Fresh | FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days. |
| FG001 | Renu Fresh / FID 114675A | Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One, 14 Days of Wear |
| |||||||||||||
| Period Two, 14 Days of Wear |
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| ID | Title | Description |
|---|---|---|
| BG000 | FID 114576A / Renu Fresh | FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days. |
| BG001 | Renu Fresh / FID 114675A |
| 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 | Lens Fit | As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements. | Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment. | Posted | Number | percentage of acceptable fit | Day 14 of lens wear |
|
Adverse events were collected for the duration of the study: 11 October 2010 through 2 February 2011.
All subjects who used study treatment or potentially used study treatment were evaluated for safety analysis.
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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 | FID 114576A | FID 114675A used for contact lens care per protocol-specified instructions for 14 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 1-888-451-3937 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| renu fresh Multi-Purpose Solution (MPS) | Device | Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours. |
|
|
| Galyfilcon A contact lenses (Acuvue Advance) | Device | A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days. |
|
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| Day 14 of lens wear |
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|
|
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Renu Fresh | Renu fresh used for contact lens care per protocol-specified instructions for 14 days. |
|
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| Secondary | Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score | The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16. | Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment. | Posted | Mean | Standard Deviation | units on a scale | Day 14 of lens wear |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | Renu Fresh | Renu fresh used for contact lens care per protocol-specified instructions for 14 days. | 0 | 89 | 0 | 89 |
Alcon reserves the right of prior review of any publication or presentation of information related to the study.