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The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) 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 |
|---|---|---|---|
| OFPM, then HMPS | Other | OPTI-FREE® PureMoist® multi-purpose 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 OFPM | Other | Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opti-Free® PureMoist® contact lens solution | Device |
|
|
| 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 122 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (121).
Subjects were recruited from 8 study centers located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | OFPM/HMPS | OPTI-FREE® PureMoist® (OFPM) multi-purpose 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. |
| FG001 | HMPS/OFPM | Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® 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 |
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| Period 2, Second 30 Days |
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This analysis population includes all subjects exposed to study lens care products (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | OFPM and 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 | OFPM | All subjects exposed to OPTI-FREE® PureMoist® multi-purpose contact lens solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee operation | Surgical and medical procedures | 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 | Jan 3, 2017 | Mar 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2016 | 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 |
|
| Habitual Contact Lenses | Device | Subject's habitual contact lens brand worn in a daily wear modality for 30 days. |
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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 per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles. |
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| 0 |
| 121 |
| 1 |
| 121 |
| 0 |
| 121 |
| EG001 | HMPS | All subjects exposed to habitual multi-purpose contact lens solution | 0 | 120 | 0 | 120 | 0 | 120 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.