Last updated: October 5, 2023
Sponsor: Coopervision, Inc.
Overall Status: Completed
Phase
N/A
Condition
Myopia
Astigmatism
Treatment
Lens A (fanfilcon A)
Lens B (asmofilcon A)
Clinical Study ID
NCT05097144
EX-MKTG-128
Ages 18-40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: A person is eligible for inclusion in the study if he/she:
- 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 contact lens wearer
- Is not a habitual wearer of either study lens
- Has a contact lens spherical prescription between +4.00 to - 10.00 (inclusive). Bestcorrected 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) orbetter in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye withthe 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 thestudy lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/dayassuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Exclusion
Exclusion Criteria: A person will be excluded from the study if he/she:
- A person was excluded from the study if he/she:
- Has a CL prescription outside the range of the available parameters of the studylenses.
- Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in eithereye.
- 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) ineither eye.
- Presence of clinically significant (grade 2-4) anterior segment abnormalities
- Presence of ocular or systemic disease or need of medications which might interferewith 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.
Study Design
Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Lens A (fanfilcon A)
Phase:
Study Start date:
August 21, 2021
Estimated Completion Date:
December 08, 2021
Study Description
Connect with a study center
National Autonomous University (UNAM)
Mexico City, Código 54090
MexicoSite Not Available

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