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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585646
• Other study ID #: CV-20-18
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2022
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Orion daily disposable contact lens
Subjects will be randomized to wear Orion lens for 2 weeks.
• Gemini daily disposable contact lens
Subjects will be randomized to wear Gemini lens for 2 weeks.

Locations

Country	Name	City	State
United States	CORL, Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Subjective Preference for Comfort	Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)	2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Post-blink Movement	Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink	2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subjective Overall Lens Handling	SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)	2 weeks