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N/A Completed N=400 Screening

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Source: ClinicalTrials.gov NCT01873846 ↗
Enrolled (actual)
400
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? — 195; 93; 92 Participants

Summary

The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.

Outcome Measures

OutcomeResultp-value
PRIMARY
Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
195; 93; 92 —
PRIMARY
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
199; 80; 101 —
PRIMARY
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
162; 51; 167 —
SECONDARY
Lens Performance Assessment
0.004 —
SECONDARY
Any Graded Slit Lamp Finding > 2
2 —

Eligibility Criteria

Inclusion Criteria

  • Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye
  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
  • Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye.
  • Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.
  • Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).
  • Subjects must habitually wear soft contact lens.
  • Subject must have no active ocular disease or allergic conjunctivitis.
  • Subject must not be using any topical ocular medications.
  • Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.
  • Subjects must habitually use a lens care product for cleaning, disinfection, and storage.

Exclusion Criteria

  • Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects with an active ocular disease or who are using any ocular medication.
  • Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
  • Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.
  • Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
  • Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.
  • Subjects with any Grade 2 or greater finding during the slit lamp examination.
  • Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects with any scar or neovascularization within the central 4 mm of the cornea.
  • Subjects who are aphakic.
  • Subjects who are amblyopic.
  • Subjects who have had any corneal surgery (eg, refractive surgery).
  • Subjects who are allergic to any component in the study care products.
  • Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01873846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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