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Search / Trial NCT05656885

Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

Launched by COOPERVISION INTERNATIONAL LIMITED (CVIL) · Dec 16, 2022

Trial Information

Current as of February 05, 2025

Completed

Keywords

ClinConnect Summary

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and signed an information consent letter.
  • Self-reports having a full eye examination in the previous two years.
  • Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
  • Has refractive astigmatism no higher than -0.75DC.
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)
  • Exclusion Criteria:
  • Is participating in any concurrent clinical or research study.
  • Has any known active ocular disease and/or infection that contraindicates contact lens wear.
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
  • Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
  • Has known sensitivity to the diagnostic sodium fluorescein used in the study.
  • Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
  • Has undergone refractive error surgery or intraocular surgery.

Trial Officials

Juan G Carracedo Rodríguez, OD,MSc,PhD

Principal Investigator

University Complutense of Madrid

About Coopervision International Limited (Cvil)

CooperVision International Limited (CVIL) is a leading global manufacturer of contact lenses and related products, dedicated to enhancing vision health and improving the quality of life for wearers worldwide. With a strong commitment to innovation and research, CVIL invests in clinical trials to develop advanced lens technologies and solutions tailored to diverse vision needs. The company operates with a focus on safety, efficacy, and customer satisfaction, ensuring that their products meet the highest standards of quality and performance. Through partnerships and collaborations, CVIL continues to drive advancements in the eye care industry while prioritizing patient outcomes and satisfaction.

Locations

Madrid, , Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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