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The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.
This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira toric lenses following a refit with Clariti toric lenses. Subject's habitual Avaira toric lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti toric lenses for 1 month of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enfilcon A | Active Comparator | All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens |
|
| somofilcon A | Experimental | All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A | Device | somofilcon A lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Enfilcon A and Somofilcon A | Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. | Baseline, 1 week, 2 week, 4 week |
| Subjective Assessments- Enfilcon A and Somofilcon A | Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied) | Baseline, 1 week, 2 week, 4 week |
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Inclusion Criteria:
Exclusion Criteria:
Is not a habitual wearer of Avaira toric lenses
Has a CL prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder less than -0.75D or more than -1.75 D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Montés-Mico, OD | Optometry Research Group (GIO) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Research Group (GIO) - Optics Department, University of Valencia | Valencia | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enfilcon A / Somofilcon A | All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study had a total of 30 participants. The 30 participants were evaluated with the habitual lenses (enfilcon A) and then evaluated with the (somofilcon A) lenses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enfilcon A / Somofilcon A | All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens |
| 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 | Visual Acuity - Enfilcon A and Somofilcon A | Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. | Posted | Mean | Standard Deviation | logMar | Baseline, 1 week, 2 week, 4 week |
|
4 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 | Enfilcon A | All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Montes-Mico, O.D., PhD | Optometry Research Group (GIO) University of Valencia | 34-9635-44764 | robert.montes@uv.es |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Somofilcon A at 2 Week | All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses. |
| OG003 | Somofilcon A at 4 Week | All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses. |
|
|
| Primary | Subjective Assessments- Enfilcon A and Somofilcon A | Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied) | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 week, 4 week |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Somofilcon A | All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens | 0 | 30 | 0 | 30 |
Principal Investigators are NOT employed by the organization sponsoring the study.
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
| Comfort prior to removal |
|
| Comfort overall |
|
| Dryness during the day |
|
| Dryness prior to removal |
|
| Overall dryness |
|
| Handling |
|
| Overall lens fit |
|
| Overall vision satisfaction |
|