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The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.
This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Contact lens | Experimental | Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses. |
|
| Control Contact lens | Active Comparator | Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Contact lens | Device | Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vision Stability While Doing Tasks on Mobile Phone | Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) | 30 minutes |
| Vision Stability While Doing Tasks on Desktop | Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) | 30 minutes |
| Vision Stability While Walking | Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit for Test Contact Lens | Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°. | 10 minutes |
| Lens Fit |
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Inclusion Criteria:
They are aged 18-35 years and have capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They are an existing wearer of soft spherical contact lenses in both eyes.
They have a spherical component of their spectacle refractive error between
-0.50DS and -6.50DS in both eyes.
They have a cylindrical component of their spectacle refractive error between
-0.75DC and -1.25DC in both eyes.
They can be fitted satisfactorily with both lens types.
They own an acceptable pair of spectacles.
They agree not to participate in other clinical research for the duration of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, PhD. | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PL | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Contact Lens Then Control Contact Lens | Subjects were randomized to wear test lenses for 30 minutes, and then cross-over to control lenses. |
| FG001 | Control Contact Lens Then Test Lens | Subjects were randomized to wear control lenses for 30 minutes, and then cross-over to test lenses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to wear either test or control lenses for 30 minutes and then cross-over to the other lens. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Vision Stability While Doing Tasks on Mobile Phone | Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
|
From baseline till 30 minutes on each study lenses, a total of 1 hour.
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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 | Test Contact Lens | Subjects were randomized to wear test lenses for 30 minutes, and then cross-over to control lenses. Test Contact lens: contact lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D, MSc., FAAO | CooperVision. Inc | 9256213761 | javega@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 | Apr 7, 2020 | Oct 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| Control Contact lens | Device | Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses. |
|
|
Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator.
| 30 minutes |
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Vision Stability While Doing Tasks on Desktop | Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
|
|
|
| Primary | Vision Stability While Walking | Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
|
|
|
| Secondary | Lens Fit for Test Contact Lens | Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°. | Posted | Number | Number of Lenses | 10 minutes |
|
|
|
| Secondary | Lens Fit | Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator. | Posted | Number | participants | 30 minutes |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Control Contact Lens | Subjects were randomized to wear control lenses for 30 minutes, and then cross-over to test lenses. Control Contact lens: contact lenses. | 0 | 27 | 0 | 27 | 0 | 27 |
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| 6-10° |
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| 11-15° |
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| 16-20° |
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| More than 20° |
|