Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2022-10-22
2022-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Lens A
All participants wore Lens A for 15 minutes (Period 1)
Lens A
Monthly Replacement Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear
Lens B
All participants wore Lens B for 15 minutes (Period 2)
Lens B
Daily Disposable Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear
Interventions
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Lens A
Monthly Replacement Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear
Lens B
Daily Disposable Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear
Eligibility Criteria
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Inclusion Criteria
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Is not a habitual wearer of either study lens
* Has a contact lens spherical prescription between +4.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye
* Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule
Exclusion Criteria
* Has a spectacle cylinder less than -0.75D or more than -2.50 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:
* Pathological dry eye or associated findings
* Pterygium, pinguecula, or corneal scars within the visual axis
* Neovascularization \> 0.75 mm in from of the limbus
* Giant papillary conjunctivitis (GCP) worse than grade 1
* Anterior uveitis or iritis (past or present)
* Seborrheic eczema, Seborrheic conjunctivitis
* History of corneal ulcers or fungal infections
* Poor personal hygiene
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rubén V Guerrero, MSc., FIACLE
Role: PRINCIPAL_INVESTIGATOR
Dr. Ruben Velazquez Private Practice
Locations
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Dr. Ruben Velazquez Private Practice
Mexico City, , Mexico
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EX-MKTG-137
Identifier Type: -
Identifier Source: org_study_id