Back to resultsA Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orion daily disposable contact lens
Gemini daily disposable contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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.
Sites / Locations
- CORL, Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Orion then Gemini
Gemini then Orion
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
Subjective Response for Overall Vision Quality
Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Subjective Response for Overall Vision Quality
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Subjective Response for Overall Vision Quality
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Secondary Outcome Measures
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)
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)
Subjective Preference for Comfort
Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)
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)
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)
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)
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)
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)
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)
Post-blink Movement
Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Post-blink Movement
Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
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)
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)
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).
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).
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)
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)
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)
Subjective Overall Lens Handling
SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04585646
Brief Title
A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
Official Title
A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orion then Gemini
Arm Type
Experimental
Arm Description
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.
Arm Title
Gemini then Orion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Orion daily disposable contact lens
Intervention Description
Subjects will be randomized to wear Orion lens for 2 weeks.
Intervention Type
Device
Intervention Name(s)
Gemini daily disposable contact lens
Intervention Description
Subjects will be randomized to wear Gemini lens for 2 weeks.
Primary Outcome Measure Information:
Title
Subjective Response for Vision Satisfaction
Description
Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time Frame
Baseline - After 10 minutes of lens dispense
Title
Subjective Response for Overall Vision Satisfaction
Description
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time Frame
2 Weeks
Title
Subjective Response for Overall Vision Satisfaction
Description
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time Frame
2 Weeks - at night
Title
Subjective Response for Overall Vision Quality
Description
Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Time Frame
Baseline - After 10 minutes of lens dispense
Title
Subjective Response for Overall Vision Quality
Description
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Time Frame
2 weeks
Title
Subjective Response for Overall Vision Quality
Description
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Time Frame
2 weeks - Night Driving
Secondary Outcome Measure Information:
Title
Subjective Overall Comfort Satisfaction
Description
Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time Frame
Baseline - After 10 minutes of lens dispense
Title
Subjective Overall Comfort Satisfaction
Description
Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time Frame
2 Weeks
Title
Subjective Preference for Comfort
Description
Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)
Time Frame
2 weeks
Title
Lens Surface Wettability Performance
Description
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)
Time Frame
Baseline - After 10 minutes of lens dispense
Title
Lens Surface Wettability Performance
Description
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)
Time Frame
2 weeks
Title
Horizontal Lens Centration
Description
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)
Time Frame
Baseline - After 10 minutes of lens dispense
Title
Horizontal Lens Centration
Description
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)
Time Frame
2 weeks
Title
Vertical Lens Centration
Description
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)
Time Frame
Baseline - After 10 minutes of lens dispense
Title
Vertical Lens Centration
Description
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)
Time Frame
2 weeks
Title
Post-blink Movement
Description
Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Time Frame
Baseline - after 10 minutes of lens dispense
Title
Post-blink Movement
Description
Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Time Frame
2 weeks
Title
Lens Horizontal Mobility Rating
Description
Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)
Time Frame
Baseline - after 10 minutes of lens dispense
Title
Lens Horizontal Mobility Rating
Description
Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)
Time Frame
2 weeks
Title
Corneal Staining Extent
Description
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).
Time Frame
Baseline - after 10 minutes of lens dispense
Title
Corneal Staining Extent
Description
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).
Time Frame
2 weeks
Title
Overall Lens Fit Acceptance
Description
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)
Time Frame
Baseline - after 10 minutes of lens dispense
Title
Overall Lens Fit Acceptance
Description
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)
Time Frame
2 weeks
Title
Lens Handling Satisfaction
Description
Lens handling satisfaction assessed on a 7-point Likert Scales (Very satisfied, satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Time Frame
2 weeks
Title
Subjective Overall Lens Handling
Description
SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pete S Kollbaum
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CORL, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
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