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OpenTrials
Completed

NCT Number: NCT05035017

Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses

The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

Indiana University School of Optometry

Bloomington, Indiana, 47405, United States

About this study

This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has had a self-reported oculo-visual examination in the last two years.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is an adapted soft contact lens wearer, having worn contact lenses for a minimum 4 weeks prior to the study
  • Has spectacle cylinder ≤1.00D in both eyes.
  • Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
  • Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
  • Wears CLs in both eyes (monovision acceptable, but not monofit)
  • Has clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination
  • Is willing to wear the study contact lenses for a minimum 8 hours on at least two consecutive days for each study pair.

Exclusion criteria

  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Is using any concomitant systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye-related clinical or research study.

Treatment and study plan

Test lens

Device

Daily disposable with modified lens design for 2 days

Control lens

Device

Daily disposable lens for 2 days

Primary outcomes

  1. Overall Comfort With Lens

    Time frame: 2 days

    Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort.

Secondary outcomes

  1. Overall Vision Quality

    Time frame: 2 days

    Participant response measured once after 2 days of wear on a 0-100 integer scale, where 0= Unacceptable, 100=Excellent Vision.

  2. Overall Lens Fit Acceptance

    Time frame: 2 days

    Measured once after 2 days of wear by investigator on lens fit alone (excludes comfort, vision, orientation) on a 0-4 scale, 0.25 steps, where 0=Can't be worn and 4=Optimum

  3. Overall Lens Handling

    Time frame: 2 days

    Participant response on overall handling (insertion, removal, and holding) of contact lenses assessed once after 2 days of wear, on the third day. Measured on a 0-100 integer scale, where 0=Cannot be managed, 100=Excellent handling.

  4. Anterior Ocular Health - Corneal Staining Extent

    Time frame: 2 days

    Assessed once after 2 days of wear with slit lamp biomicroscopy and graded on a 0-4 integer scale, where 0=No Staining and 4=>45% of area. Lower values represented a better outcome, e.g., a grading value of 1 would represent less corneal staining than a grade of 4. Locations (central, nasal, temporal, superior, inferior) were graded separately.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2021
Registry last updated
Aug 12, 2024

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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