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Completed
NCT05688657
Clinical Evaluation of Two Toric Contact Lenses
Conditions: Astigmatism
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 40
Sponsor: Coopervision, Inc.
Location: Mexico
Summary
The study objective was to compare short-term clinical performance data of two toric contact lenses.
Eligibility Criteria
Inclusion Criteria:Is between 18 and 40 years of age (inclusive)Has had a self-reported visual exam in the last two yearsIs an adapted soft contact lens wearerIs not a habitual wearer of either study lensHas a contact lens spherical prescription between +4.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eyeHave 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 diseaseHas 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 scheduleExclusion Criteria: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 -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 abnormalitiesPresence 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 findingsPterygium, pinguecula, or corneal scars within the visual axisNeovascularization > 0.75 mm in from of the limbusGiant papillary conjunctivitis (GCP) worse than grade 1Anterior uveitis or iritis (past or present)Seborrheic eczema, Seborrheic conjunctivitisHistory of corneal ulcers or fungal infectionsPoor personal hygieneHas 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.
Source: ClinicalTrials.gov (NCT05688657). StuddyBuddy aggregates publicly available trial information.