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Completed

NCT Number: NCT04585646

A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens

The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CORL, Indiana University

Bloomington, Indiana, 47405, United States

About this study

The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear. This is a double-masked, randomized, bilateral, two-week crossover, dispensing study.

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.
  • Is no greater than 55 years of age.
  • 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 lenses for a minimum of 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 per day/6 days per week

Exclusion criteria

  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Is using any 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 strabismus/amblyopia.
  • Has undergone corneal refractive surgery.
  • Is pregnant, lactating or planning a pregnancy.
  • Is participating in any concurrent clinical or research study.

Treatment and study plan

Orion daily disposable contact lens

Device

Subjects will be randomized to wear Orion lens for 2 weeks.

Gemini daily disposable contact lens

Device

Subjects will be randomized to wear Gemini lens for 2 weeks.

Primary outcomes

  1. Subjective Response for Vision Satisfaction

    Time frame: Baseline - After 10 minutes of lens dispense

    Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  2. Subjective Response for Overall Vision Satisfaction

    Time frame: 2 Weeks

    Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  3. Subjective Response for Overall Vision Satisfaction

    Time frame: 2 Weeks - at night

    Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  4. Subjective Response for Overall Vision Quality

    Time frame: Baseline - After 10 minutes of lens dispense

    Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

  5. Subjective Response for Overall Vision Quality

    Time frame: 2 weeks

    Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

  6. Subjective Response for Overall Vision Quality

    Time frame: 2 weeks - Night Driving

    Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

Secondary outcomes

  1. Subjective Overall Comfort Satisfaction

    Time frame: Baseline - After 10 minutes of lens dispense

    Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  2. Subjective Overall Comfort Satisfaction

    Time frame: 2 Weeks

    Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  3. Subjective Preference for Comfort

    Time frame: 2 weeks

    Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)

  4. Lens Surface Wettability Performance

    Time frame: Baseline - After 10 minutes of lens dispense

    Lens Surface wettability performance was measured on a scale of 0-4, 0.25 steps (0-Very poor, 1 - Poor, 2- Acceptable, 3- Good, 4- Excellent)

  5. Lens Surface Wettability Performance

    Time frame: 2 weeks

    Lens Surface wettability performance was measured on a scale of 0-4, 0.25 steps (0-Very poor, 1 - Poor, 2- Acceptable, 3- Good, 4- Excellent)

  6. Horizontal Lens Centration

    Time frame: Baseline - After 10 minutes of lens dispense

    Horizontal Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Nasal decentration given +ve value. temporal decentration given -ve value)

  7. Horizontal Lens Centration

    Time frame: 2 weeks

    Horizontal Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Nasal decentration given +ve value. temporal decentration given -ve value)

  8. Vertical Lens Centration

    Time frame: Baseline - After 10 minutes of lens dispense

    Vertical Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Superior decentration given +ve value, inferior decentration given -ve value)

  9. Vertical Lens Centration

    Time frame: 2 weeks

    Vertical Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Superior decentration given +ve value, inferior decentration given -ve value)

  10. Post-blink Movement

    Time frame: Baseline - after 10 minutes of lens dispense

    Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink

  11. Post-blink Movement

    Time frame: 2 weeks

    Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink

  12. Lens Horizontal Mobility Rating

    Time frame: Baseline - after 10 minutes of lens dispense

    Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)

  13. Lens Horizontal Mobility Rating

    Time frame: 2 weeks

    Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)

  14. Corneal Staining Extent

    Time frame: Baseline - after 10 minutes of lens dispense

    Corneal staining extent will be assessed on a scale of 0-4 (0- No Staining, 1- 1 to 15% of area, 2- 16 to 30% of area, 3- 31-45% of area, 4- >45% of area).

  15. Corneal Staining Extent

    Time frame: 2 weeks

    Corneal staining extent will be assessed on a scale of 0-4 (0- No Staining, 1- 1 to 15% of area, 2- 16 to 30% of area, 3- 31-45% of area, 4- >45% of area).

  16. Overall Lens Fit Acceptance

    Time frame: Baseline - after 10 minutes of lens dispense

    Overall Lens Fit Acceptance assessed on a scale of 0-4 (0-Can't be worn, 1- Poor but acceptable, 2- Fair, 3- Good, 4- Optimum)

  17. Overall Lens Fit Acceptance

    Time frame: 2 weeks

    Overall Lens Fit Acceptance assessed on a scale of 0-4 (0-Can't be worn, 1- Poor but acceptable, 2- Fair, 3- Good, 4- Optimum)

  18. Lens Handling Satisfaction

    Time frame: 2 weeks

    Lens handling satisfaction assessed on a 7-point Likert Scales (Very satisfied, satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  19. Subjective Overall Lens Handling

    Time frame: 2 weeks

    SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
May 10, 2022

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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