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OpenTrials
Completed

NCT Number: NCT05656885

Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Complutense of Madrid

Madrid, 28037, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lens A

Device

Soft spherical hydrogel contact lens for 15 minutes

Lens B

Device

Soft spherical silicone hydrogel contact lens for 15 minutes

Primary outcomes

  1. Lens Fit Acceptance Rating

    Time frame: 15 minutes

    Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of Proclear Monthly and Avaira Vitality

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2022
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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