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The purpose of this study was to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market.
This was an interventional, prospective, open label, sequential design study. Participants wore each study contact lens on a daily disposable wearing modality for 14 ± 3 days and attended the clinic for a total of three study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens 1 | Experimental | All participants wore Lens 1 for 14 ± 3 days (Period 1) |
|
| Lens 2 | Experimental | All participants wore Lens 2 for 14 ± 3 days (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens 1 | Device | Frequent replacement silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Handling | The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Overall logMAR Visual Acuity - Dominant Eye | The mean logMAR visual acuity of the dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit. | 14 days |
| Overall logMAR Visual Acuity - Non-Dominant Eye |
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Inclusion Criteria:
Age 40 years and older;
Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal);
Spectacle refraction:
Best corrected visual acuity of at least 20/25 in each eye. - The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.
Exclusion Criteria:
To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study. The following are specific criteria that exclude a candidate from enrolment in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Guillon, PhD FCOptom | mguillon@otg.co.uk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Technology Group - International | London | SW1E6AU | United Kingdom |
A total of 67 potential participants were screened, one participant did not fulfil the entry criteria (prescription out of range).
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| ID | Title | Description |
|---|---|---|
| FG000 | Frequent Replacement Silicone Hydrogel Contact Lens (Lens 1) | All participants wore Lens 1 for 14 ± 3 days (Period 1) |
| FG001 | Daily Disposable Silicone Hydrogel Contact Lens (Lens 2) | All participants wore Lens 2 for 14 ± 3 days (Period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lens 1, 14 ± 3 Days |
| |||||||||||||
| Lens 2, 14 ± 3 Days |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes study participants that completed all study visits |
| 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 Lens Handling | The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses | Posted | Median | Standard Deviation | score on a scale | 1 week |
|
|
Duration of the study, approximately 1 month
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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 | Lens 1 | Participants that received Lens 1 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega | CooperVision Inc. | +1 (925) 621-3761 | JVega2@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 | Dec 11, 2023 | May 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens 2 | Device | Daily disposable silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality |
|
The mean logMAR visual acuity of the non-dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit. |
| 14 days |
| Overall logMAR Visual Acuity - Binocular | The mean binocular logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit. | 14 days |
| NOT COMPLETED |
|
| 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 |
|
| Participants |
|
|
| Secondary | Overall logMAR Visual Acuity - Dominant Eye | The mean logMAR visual acuity of the dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit. | Posted | Mean | Standard Deviation | logMAR | 14 days |
|
|
|
| Secondary | Overall logMAR Visual Acuity - Non-Dominant Eye | The mean logMAR visual acuity of the non-dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit. | Posted | Mean | Standard Deviation | logMAR | 14 days |
|
|
|
| Secondary | Overall logMAR Visual Acuity - Binocular | The mean binocular logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit. | Posted | Mean | Standard Deviation | logMAR | 14 days |
|
|
|
| 66 |
| 0 |
| 66 |
| 4 |
| 66 |
| EG001 | Lens 2 | Participants that received Lens 2 | 0 | 66 | 0 | 66 | 6 | 66 |
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Itchy Eye | Eye disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
| Common Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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