MyopiaNCT04585646

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

A study testing Orion daily disposable contact lens and Gemini daily disposable contact lens in people with Myopia, run by CooperVision, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Orion daily disposable contact lens and Gemini daily disposable contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 14 Sep 2020to 31 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

CORL, Indiana University
Bloomington, Indiana, 47405

Other trials in 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.

Read the 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.

Conditions: Myopia
Being tested: Orion daily disposable contact lens, Gemini daily disposable contact lens
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04585646
Study group	Role	What they receive
Orion then Gemini	Experimental	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. Receives: Device: Orion daily disposable contact lens; Device: Gemini daily disposable contact lens
Gemini then Orion	Experimental	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. Receives: Device: Orion daily disposable contact lens; Device: Gemini daily disposable contact lens

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 weeks - Night Driving

Secondary outcomes (19)

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)
Measured: 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)
Measured: 2 Weeks
Subjective Preference for Comfort
Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 weeks
Post-blink Movement
Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 weeks
Subjective Overall Lens Handling
SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202031 Dec 2020

First posted14 Oct 2020
Study start14 Sep 2020
Primary completion30 Nov 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04585646
Sponsor's protocol ID: CV-20-18
Status last verified: Apr 2022
First submitted: 5 Oct 2020
Last updated: 10 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
ClinicalTrials.gov ID: NCT04585646
Acronym / sponsor ID: CV-20-18
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 14 Sep 2020 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 14 Oct 2020 (actual)
Results: Posted 10 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Orion then Gemini	Experimental	Device: Orion daily disposable contact lens, Device: Gemini daily disposable contact lensSubjects 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.
Gemini then Orion	Experimental	Device: Orion daily disposable contact lens, Device: Gemini daily disposable contact lensSubjects 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Orion daily disposable contact lensSubjects will be randomized to wear Orion lens for 2 weeks.	Device	Gemini then Orion, Orion then Gemini
Gemini daily disposable contact lensSubjects will be randomized to wear Gemini lens for 2 weeks.	Device	Gemini then Orion, Orion then Gemini

Primary outcome

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)
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)
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)
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)
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)
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)

19 secondary outcomes

Subjective Overall Comfort Satisfaction
Time frame: Baseline - After 10 minutes of lens dispense
Subjective Overall Comfort Satisfaction
Time frame: 2 Weeks
Subjective Preference for Comfort
Time frame: 2 weeks
Lens Surface Wettability Performance
Time frame: Baseline - After 10 minutes of lens dispense
Lens Surface Wettability Performance
Time frame: 2 weeks
Horizontal Lens Centration
Time frame: Baseline - After 10 minutes of lens dispense
Horizontal Lens Centration
Time frame: 2 weeks
Vertical Lens Centration
Time frame: Baseline - After 10 minutes of lens dispense
Vertical Lens Centration
Time frame: 2 weeks
Post-blink Movement
Time frame: Baseline - after 10 minutes of lens dispense
Post-blink Movement
Time frame: 2 weeks
Lens Horizontal Mobility Rating
Time frame: Baseline - after 10 minutes of lens dispense
Lens Horizontal Mobility Rating
Time frame: 2 weeks
Corneal Staining Extent
Time frame: Baseline - after 10 minutes of lens dispense
Corneal Staining Extent
Time frame: 2 weeks
Overall Lens Fit Acceptance
Time frame: Baseline - after 10 minutes of lens dispense
Overall Lens Fit Acceptance
Time frame: 2 weeks
Lens Handling Satisfaction
Time frame: 2 weeks
Subjective Overall Lens Handling
Time frame: 2 weeks

Results and safety

Results posted to the registry on 10 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Orion Then Gemini	32	31
Gemini Then Orion	32	28

Primary outcome: Subjective Response for Vision Satisfaction

Time frame: Baseline - After 10 minutes of lens dispense. Count of participants. Unit: Participants

Measure	Orion n = 59	Gemini n = 59
Very satisfied	24	28
Satisfied	30	24
Somewhat Satisfied	4	7
Neither	1	0
Somewhat Dissatisfied	0	0
Dissatisfied	0	0
Very Dissatisfied	0	0

Primary outcome: Subjective Response for Overall Vision Satisfaction

Time frame: 2 Weeks. Count of participants. Unit: Participants

Measure	Orion n = 59	Gemini n = 59
Very satisfied	26	28
Satisfied	22	24
Somewhat Satisfied	7	5
Neither	0	1
Somewhat Dissatisfied	3	1
Dissatisfied	1	0
Very Dissatisfied	0	0

Primary outcome: Subjective Response for Overall Vision Satisfaction

Time frame: 2 Weeks - at night. Number. Unit: percentage of participants

Measure	Orion n = 59	Gemini n = 59
Very satisfied	42	34
Satisfied	41	48
Somewhat Satisfied	8	10
Neither	7	3
Somewhat Dissatisfied	2	5
Dissatisfied	0	0
Very Dissatisfied	0	0

Primary outcome: Subjective Response for Overall Vision Quality

Time frame: Baseline - After 10 minutes of lens dispense. Mean (Standard Deviation). Unit: units on a scale

Measure	Orion n = 59	Gemini n = 59
Value	90 (8)	91 (9)

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to 2 weeks on each study lens, a total of 4 weeks,. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Orion	0 of 64 (0%)	0 of 64 (0%)	0 of 64
Gemini	0 of 64 (0%)	0 of 64 (0%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pete S Kollbaum principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Orion daily disposable contact lens and Gemini daily disposable contact lens in people with Myopia, run by CooperVision, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Response for Vision Satisfaction (time frame: Baseline - After 10 minutes of lens dispense). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.