Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
NCT ID: NCT03098745
Last Updated: 2019-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-02-01
2017-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Omafilcon A
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A
contact lens
Somofilcon A
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Somofilcon A
contact lens
Omafilcon A - Proclear (PC)
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC)
contact lens
Interventions
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Omafilcon A
contact lens
Somofilcon A
contact lens
Omafilcon A - Proclear (PC)
contact lens
Eligibility Criteria
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Inclusion Criteria
* Is between 18 and 40 years of age (inclusive).
* Has had a self-reported visual exam in the last two years.
* Is an adapted soft CL (Contact Lens) wearer who is not wearing any of the study lenses.
* Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
* Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
* 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.
* Is willing to comply with the visit schedule.
Exclusion Criteria
* Has never worn contact lenses before.
* Currently wears rigid gas permeable contact lenses.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has a CL prescription outside the range of - 1.00 to - 6.00D
* Has a spectacle cylinder ≥1.00D of cylinder in either eye.
* 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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Ruben Velázquez Guerrero, MSc., FIACLE
Role: PRINCIPAL_INVESTIGATOR
National Autonomous University, School of Optometry
Locations
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Optometry Clinic, National Autonomous University
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-79
Identifier Type: -
Identifier Source: org_study_id
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