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The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCP, then HMPS | Other | 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. |
|
| HMPS, then CCP | Other | Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix | Device | For cleaning, disinfection and overnight storage of contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30 | CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms. | Day 30, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Project Manager, CPM | Alcon, A Novartis Division | Study Director |
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Of the 126 enrolled, 5 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (121).
Subjects were recruited from 9 study centers located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | CCP/HMPS | 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution (CCP) in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. |
| FG001 | HMPS/CCP | Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 30 Days of Wear |
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| Period 2, Second 30 Days of Wear |
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This analysis set includes all randomized subjects who were exposed to at least one of the study lens care products evaluated in this study (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix and subject's HMPS used during Period 1 and Period 2 in a crossover assignment. |
| 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 | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30 | CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms. | Full Analysis Set with non-missing responses | Posted | Mean | Standard Deviation | units on a scale | Day 30, each product |
|
Day 1 through study completion, an average of 60 days
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
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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 | CLEAR CARE PLUS | All subjects exposed to CCP contact lens solution | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, CDMA Vision Care Franchise | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2016 | Mar 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2015 | Mar 27, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Habitual Multi-Purpose Contact Lens Solution | Device |
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| Habitual Contact Lenses | Device | Participant's habitual contact lens brand worn in a daily wear modality for 30 days. |
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| Protocol Violation |
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| Withdrawal by Subject |
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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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Subject's habitual multi-purpose contact lens solution used daily with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. |
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|
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| 121 |
| 0 |
| 121 |
| 0 |
| 121 |
| EG001 | HMPS | All subjects exposed to habitual multi-purpose contact lens solution | 0 | 121 | 1 | 121 | 0 | 121 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.