AstigmatismNCT04016623
Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
A study testing 1-day toric test contact lens in people with Astigmatism, run by CooperVision, Inc. at 1 site in United States.
Trial summary
An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- 1-day toric test contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 4 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination
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.
Show all 9Show fewer
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, 47405
About this study
An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.
Read the detailed description
A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.
Each subject will be asked to wear four pairs of contact lenses in the study
- Conditions
- Astigmatism
- Being tested
- 1-day toric test contact lens, 1-day toric control contact lens
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-day toric test contact lensDevice
Also called Test contact lens, Invigor toric 1-day contact lens
somofilcon A 1-day toric test contact lens
1-day toric control contact lensDevice
Also called Control contact lens
somofilcon A 1-day toric control contact lens
| Study group | Role | What they receive |
|---|---|---|
| 1-day toric test contact lens | Experimental | Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens). Receives: Device: 1-day toric test contact lens; Device: 1-day toric control contact lens |
| 1-day toric control contact lens | Active comparator | Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens). Receives: Device: 1-day toric test contact lens; Device: 1-day toric control contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility of Toric Mark
Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Degree of Lens Orientation
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: Baseline
Degree of Lens Orientation
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Degree of Lens Orientation
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Toric Stability
Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Toric Stability
Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Degree of Rotational Recovery
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Degree of Rotational Recovery
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Toric Fit Acceptance
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Toric Fit Acceptance
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Toric Fit Preference
Investigator's toric fitting preference - Test lens , No Preference , Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: Baseline
Toric Fit Preference
Investigator's toric fitting preference - Test lens, No Preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Secondary outcomes (16)
Measurement of Lens Horizontal Centration
Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 Minutes
Measurement of Lens Horizontal Centration
Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Measurement of Lens Vertical Centration
Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Measurement of Lens Vertical Centration
Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Measurement of Lens Movement
Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Measurement of Lens Movement
Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Lens Push-Up
Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Lens Push-Up
Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).
Measured: 1 hour
Primary Lens Gaze Lag
Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Primary Lens Gaze Lag
Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
General Lens Fit Acceptance
General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
General Lens Fit Acceptance
General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Up Gaze Lag
Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 15 minutes
Up Gaze Lag
Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
General Lens Fit Preference
Investigator's general lens fit preference - Test lens, No preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: Baseline
General Lens Fit Preference
Investigator's general lens fit preference - Test lens, No preference, Control lens.
Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start6 May 2019
- Primary completion15 May 2019
- Study completion4 Jun 2019
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 AstigmatismStudies 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
- Factorial
- Model description
- This is a non-dispensing, double-masked, randomized, contralateral study design. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pete S Kollbaum, OD PhD, Principal investigator, Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016623
- Sponsor's protocol ID
- CV-19-27
- Status last verified
- Aug 2020
- First submitted
- 14 May 2019
- Last updated
- 14 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
- ClinicalTrials.gov ID
- NCT04016623
- Acronym / sponsor ID
- CV-19-27
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.
Detailed description
A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.
Each subject will be asked to wear four pairs of contact lenses in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a non-dispensing, double-masked, randomized, contralateral study design. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
| Arm | Type | Receives |
|---|---|---|
| 1-day toric test contact lens | Experimental | Device: 1-day toric test contact lens, Device: 1-day toric control contact lensEach subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens). |
| 1-day toric control contact lens | Active comparator | Device: 1-day toric test contact lens, Device: 1-day toric control contact lensEach subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Key exclusion criteria (9 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 |
|---|---|---|
| 1-day toric test contact lensAlso: Test contact lens, Invigor toric 1-day contact lenssomofilcon A 1-day toric test contact lens | Device | 1-day toric control contact lens, 1-day toric test contact lens |
| 1-day toric control contact lensAlso: Control contact lenssomofilcon A 1-day toric control contact lens | Device | 1-day toric control contact lens, 1-day toric test contact lens |
Primary outcome
Visibility of Toric Mark
Time frame: 1 hour
Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation
Time frame: Baseline
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation
Time frame: 15 minutes
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation
Time frame: 1 hour
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Stability
Time frame: 15 minutes
Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Stability
Time frame: 1 hour
Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Rotational Recovery
Time frame: 15 minutes
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Rotational Recovery
Time frame: 1 hour
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Acceptance
Time frame: 15 minutes
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Acceptance
Time frame: 1 hour
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Preference
Time frame: Baseline
Investigator's toric fitting preference - Test lens , No Preference , Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Preference
Time frame: 1 hour
Investigator's toric fitting preference - Test lens, No Preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
16 secondary outcomes
Measurement of Lens Horizontal Centration
Time frame: 15 Minutes
Measurement of Lens Horizontal Centration
Time frame: 1 hour
Measurement of Lens Vertical Centration
Time frame: 15 minutes
Measurement of Lens Vertical Centration
Time frame: 1 hour
Measurement of Lens Movement
Time frame: 15 minutes
Measurement of Lens Movement
Time frame: 1 hour
Lens Push-Up
Time frame: 15 minutes
Lens Push-Up
Time frame: 1 hour
Primary Lens Gaze Lag
Time frame: 15 minutes
Primary Lens Gaze Lag
Time frame: 1 hour
General Lens Fit Acceptance
Time frame: 15 minutes
General Lens Fit Acceptance
Time frame: 1 hour
Up Gaze Lag
Time frame: 15 minutes
Up Gaze Lag
Time frame: 1 hour
General Lens Fit Preference
Time frame: Baseline
General Lens Fit Preference
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, OD PhD principal investigator
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, 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 1-day toric test contact lens in people with Astigmatism, 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 8 inclusion and 9 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 14 Aug 2020. 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 3 Aug 2020). 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?
Visibility of Toric Mark (time frame: 1 hour). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2020.