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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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The purpose of this study was to assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens.
This was a prospective, single group, dispensing clinical trial to determine subjective and objective visual performance measures, patient satisfaction and adaptability to a commercially available daily disposable contact lens in myopic young adults over 3 months of daily lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily disposable contact lens | Experimental | Participants wore a daily disposable contact lens for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daily disposable contact lens | Device | Daily disposable contact lens for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Quality of Vision (QoV) | The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Impact on Quality of Life (CLIQ) | Participant quality of life was measured after 3 months of lens wear using a CLIQ 28-item questionnaire. Each question was scored on a 1-5 integer scale, where 1=never and 5=always. As written, scores were not consistently associated with a better or worse outcome. An algorithm was later applied for consistency (i.e., for categories [1,2,3,4,5], for the first 20 questions [5,4,3,3,3] are assigned and for 21-28 [2,2,3,4,5]). After the conversion, the average of all scores was used to measure the CLIQ. The CLIQ score ranged from a minimum of 2.71 to a maximum of 5, with 5 representing the best score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daily Disposable Contact Lens | Participants wore a daily disposable contact lens for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Twenty-nine participants enrolled in the study and 27 completed the study. Demographic information was recorded for the 2 discontinued patients and therefore included in the baseline population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Disposable Contact Lens | Participants wore a daily disposable contact lens for 3 months. |
| 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 | Subjective Quality of Vision (QoV) | The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms. | The 2 discontinuations occurred after lens dispensing but prior to the first follow up visit. These participants were excluded from the data analysis population. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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The duration of the study, approximately 3 months.
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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 | Daily Disposable Contact Lens | Participants wore a daily disposable contact lens for 3 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal infiltrates | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Chamberlain | CooperVision Inc. | +19257306754 | pchamberlain@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2021 | May 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Daily Disposable Contact Lens |
Participants wore a daily disposable contact lens for 3 months. |
|
|
| Secondary | Contact Lens Impact on Quality of Life (CLIQ) | Participant quality of life was measured after 3 months of lens wear using a CLIQ 28-item questionnaire. Each question was scored on a 1-5 integer scale, where 1=never and 5=always. As written, scores were not consistently associated with a better or worse outcome. An algorithm was later applied for consistency (i.e., for categories [1,2,3,4,5], for the first 20 questions [5,4,3,3,3] are assigned and for 21-28 [2,2,3,4,5]). After the conversion, the average of all scores was used to measure the CLIQ. The CLIQ score ranged from a minimum of 2.71 to a maximum of 5, with 5 representing the best score. | The 2 discontinuations occurred after lens dispensing but prior to the first follow up visit. These participants were excluded from the data analysis population. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 4 |
| 27 |
| Burn | General disorders | Systematic Assessment | Burns on leg due to spilled drink. Unrelated to lens. |
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| Corneal staining | Eye disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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