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N/A N=53 Randomized Double-blind Treatment

Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

Myopia · Hyperopia

Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Lens Handling on Removal — 84; 89 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lens A (fanfilcon A) (Device); Lens B (lotrafilcon B) (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Apr 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Handling on Removal
84; 89

Summary

The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Eligibility Criteria

Inclusion Criteria

  • Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
  • Had read and signed an information consent letter;
  • Were willing and able to follow instructions and maintain the appointment schedule;
  • Self-reported having had a full eye examination in the previous two years;
  • Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
  • Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
  • Habitually wore spherical soft contact lenses, for the past 3 months minimum:

It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;

  • For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
  • Had refractive astigmatism no higher than -0.75DC in each eye;
  • Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion Criteria

  • Were participating in any concurrent clinical or research study;
  • Had any known active ocular disease and/or infection that contraindicated contact lens wear;
  • Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
  • Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
  • Had known sensitivity to the diagnostic sodium fluorescein used in the study;
  • Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Had undergone refractive error surgery or intraocular surgery.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06098339). 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.

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