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The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.
This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lenses, then Test Lenses | Experimental | Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week. |
|
| Test Lenses, then Control Lens | Experimental | Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Lenses (control fitting approach) | Device | Daily wear multifocal lenses for 1 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision Satisfaction | Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied | One week |
| Overall Lens Preference | Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference' | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Binocular Visual Acuity Index | Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities | One week |
| Number of Contact Lenses |
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Inclusion Criteria:
Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D & +1.75D
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Guillon, PhD, FCOptom | Ocular Technology Group - International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Technology Group - International | London | SW1E 6AU | United Kingdom |
Twenty-five participants were screened and subsequently enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Lenses, Then Test Lenses | Participants first wore Control Lenses for 1 week (Period 1) and then wore Test Lenses for 1 week (Period 2) |
| FG001 | Test Lenses, Then Control Lenses | Participants first wore Test Lenses for 1 week (Period 1) and then wore Control Lenses for 1 week (Period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (One Week) |
| |||||||||||||
| Period 2 (One Week) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | Includes all study participants. |
| 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 | Overall Vision Satisfaction | Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied | Posted | Mean | Standard Deviation | score on a scale | One week |
|
Duration of the study, approximately 2 weeks
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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 | Control Lenses | Participants that received Control Lenses during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Percy Lazon de la Jara BOptom PhD | CooperVision Inc. | +1-925-251-6682 | PLazon@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 | Aug 8, 2022 | Nov 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Test Lenses (test fitting approach) | Device | Daily wear multifocal lenses for 1 week |
|
This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense. |
| One week |
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|
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Overall Lens Preference | Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference' | Posted | Count of Participants | Participants | Two weeks |
|
|
|
| Secondary | Overall Binocular Visual Acuity Index | Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities | Posted | Mean | Standard Deviation | logMAR | One week |
|
|
|
| Secondary | Number of Contact Lenses | This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense. | Posted | Mean | Standard Error | number of contact lenses (pair) | One week |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Test Lenses | Participants that received Test Lenses during either the first or second period of the study. | 0 | 25 | 0 | 25 | 0 | 25 |
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