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N/A Completed N=249 Randomized Double-blind Treatment

Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Source: ClinicalTrials.gov NCT04980456 ↗
Enrolled (actual)
249
Serious AEs
0.1%
Results posted
Jan 2023
Primary outcomePrimary: Least Squares Mean Distance VA (logMAR) With Study Lenses — -0.07; -0.08 logMAR

Summary

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Outcome Measures

OutcomeResultp-value
PRIMARY
Least Squares Mean Distance VA (logMAR) With Study Lenses
-0.07; -0.08

Eligibility Criteria

Inclusion Criteria

  • Able to understand and sign an approved Informed Consent form;
  • Willing and able to attend all scheduled study visits as required by the protocol;
  • Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
  • Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study participation.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
  • Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
  • Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
  • Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
  • Other protocol-defined exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04980456). 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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