Comparative Study of Two Marketed Spherical Soft Contact Lenses
NCT ID: NCT01582789
Last Updated: 2020-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2012-04-09
2012-07-31
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
SINGLE
Study Groups
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enfilcon A/senofilcon A
Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks.
enfilcon A
enfilcon A daily wear soft contact lens
senofilcon A
senofilcon A daily wear soft contact lens
senofilcon A/enfilcon A
Subjects were randomized to wear senofilcon A then enfilcon A for two weeks
enfilcon A
enfilcon A daily wear soft contact lens
senofilcon A
senofilcon A daily wear soft contact lens
Interventions
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enfilcon A
enfilcon A daily wear soft contact lens
senofilcon A
senofilcon A daily wear soft contact lens
Eligibility Criteria
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Inclusion Criteria
* Based on his/her knowledge, must be in good general health.
* Be 18 to 38 years old.
* Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
* Read, indicate understanding of, and sign Written Informed Consent.
* Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses being evaluated in this trial.
* Require a visual correction in both eyes.
* Require a prescription between +8.00D and -12.00D and have less than -0.75D of astigmatism in both eyes.
* Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
* Must be able to wear their lenses at least 10 working days over the next 2-weeks; \> 8 hours/day assuming there are no contraindications for doing so.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia; no evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes); no clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection); no other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology); no aphakia
Exclusion Criteria
* Greater than 0.50D of refractive astigmatism in either eye.
* Presbyopic or current monovision contact lens wear.
* Cannot be currently wearing of either lenses (Avaira or Oasys)
* Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
* Presence of ocular or systemic disease or need of medication 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 the limbus, giant papillary conjunctivitis (GPC) worse than Grade 1; anterior uveitis or iritis (past or present), seborrheic eczema, seborrheic conjunctivitis, history of corneal ulcer or fungal infections; poor personal hygiene
* A known history of corneal hypoesthesia (reduced corneal sensitivity).
* Contact lens best corrected Snellen visual acuities (VA) worse than 20/30.
* Aphakia, Keratoconus or a highly irregular cornea
18 Years
38 Years
ALL
Yes
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Don Siegel, OD
Role: STUDY_DIRECTOR
CooperVision, Inc.
Locations
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Advanced Eyecare
Pismo Beach, California, United States
Eric M. White, OD, Inc.
San Diego, California, United States
Countries
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Other Identifiers
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EX-MKTG-37
Identifier Type: -
Identifier Source: org_study_id