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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Orion daily disposable contact lens; Device: Gemini daily disposable contact lens

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • CORL, Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Orion then Gemini; Subjects will be randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.	Device: Orion daily disposable contact lens; Subjects will be randomized to wear Orion lens for 2 weeks.; Device: Gemini daily disposable contact lens; Subjects will be randomized to wear Gemini lens for 2 weeks.
EXPERIMENTAL: Gemini then Orion; Subjects will be randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.	Device: Orion daily disposable contact lens; Subjects will be randomized to wear Orion lens for 2 weeks.; Device: Gemini daily disposable contact lens; Subjects will be randomized to wear Gemini lens for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Response for Vision Satisfaction	Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)	Baseline - After 10 minutes of lens dispense
Subjective Response for Overall Vision Satisfaction	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 Weeks
Subjective Response for Overall Vision Satisfaction	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 Weeks - at night
Subjective Response for Overall Vision Quality	Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)	Baseline - After 10 minutes of lens dispense
Subjective Response for Overall Vision Quality	Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)	2 weeks
Subjective Response for Overall Vision Quality	Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)	2 weeks - Night Driving

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Overall Comfort Satisfaction	Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)	Baseline - After 10 minutes of lens dispense
Subjective Overall Comfort Satisfaction	Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)	2 Weeks
Subjective Preference for Comfort	Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)	2 weeks
Lens Surface Wettability Performance	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)	Baseline - After 10 minutes of lens dispense
Lens Surface Wettability Performance	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)	2 weeks
Horizontal Lens Centration	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)	Baseline - After 10 minutes of lens dispense
Horizontal Lens Centration	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)	2 weeks
Vertical Lens Centration	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)	Baseline - After 10 minutes of lens dispense
Vertical Lens Centration	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)	2 weeks
Post-blink Movement	Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink	Baseline - after 10 minutes of lens dispense
Post-blink Movement	Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink	2 weeks
Lens Horizontal Mobility Rating	Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)	Baseline - after 10 minutes of lens dispense
Lens Horizontal Mobility Rating	Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)	2 weeks
Corneal Staining Extent	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).	Baseline - after 10 minutes of lens dispense
Corneal Staining Extent	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).	2 weeks
Overall Lens Fit Acceptance	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)	Baseline - after 10 minutes of lens dispense
Overall Lens Fit Acceptance	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)	2 weeks
Lens Handling Satisfaction	Lens handling satisfaction assessed on a 7-point Likert Scales (Very satisfied, satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)	2 weeks
Subjective Overall Lens Handling	SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)	2 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Pete S Kollbaum, Indiana University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2020
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-20-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes