MyopiaNCT03722784

Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear

A study testing Invigor A (test) in people with Myopia and Hyperopia, run by CooperVision, Inc. at 6 sites 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 aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia, Hyperopia, Astigmatism
What is being tested?: Invigor A (test)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 6 sitesUnited States
Study dates: 10 Oct 2018to 1 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be at least 18 years of age as of the date of evaluation for the study
Have
Read the informed consent document
Been given an explanation of the informed consent document
indicated understanding of the informed consent document
Signed the informed consent document

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Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments.
Be an adapted, frequent replacement, current full - time silicone hydrogel or soft contact lens wearer. An adapted full- time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
Be in good general health, based on his/her knowledge.

Who cannot join

Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
Poor personal hygiene.
Any active participation in another clinical trial during this trial or within 30 days prior to this study.
To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
A member, relative or household member of the investigator(s) or of the investigational office staff.
A known sensitivity to the ingredients used in the multi-purpose solution approved for use in the study and is unable or unwilling to use the alternate care system.

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Had previous refractive surgery; or current or previous orthokeratology treatment.
Aphakic or pseudophakic.
Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
A history of papillary conjunctivitis that has interfered with contact lens wear.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Quinn, Foster & Associates
Athens, Ohio, 45701
Primary Eyecare Group, P.C
Brentwood, Tennessee, 37027-7552
Vision Care Associates
East Lansing, Michigan, 48823
The Koetting Associates
St Louis, Missouri, 63144
Mark Nakano. O.D
Torrance, California, 90503
Ziegler Leffingwell Eye Center
West Allis, Wisconsin, 53227

Other trials in United States

About this study

Official title: Evaluation of the CooperVision, Inc. Invigor A and Invigor B Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear

The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.

Read the detailed description

This study is a multi-centered, daily wear, monthly replacement, bilateral, randomized in a ratio of two to one (2:1) Test to Control, lens blocked (subjects remain in the same lens brand throughout the study), licensed investigator and subject masked, concurrent controlled study with a study duration of approximately three months evaluating performance equivalence of Invigor A (test) over Invigor B (control) contact lenses.

Conditions: Myopia, Hyperopia, Astigmatism
Being tested: Invigor A (test), Invigor B (control)
Medical subject headings: Myopia, Hyperopia, Astigmatism

What participants receive

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

Invigor A (test)Device
silicone hydrogel lens
Invigor B (control)Device
silicone hydrogel lens

Study groups in NCT03722784
Study group	Role	What they receive
Invigor A (test)	Experimental	Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study. Receives: Device: Invigor A (test)
Invigor B (Control)	Active comparator	Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study. Receives: Device: Invigor B (control)

What is being measured

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

Number of Eyes With Epithelial Edema - Slit Lamp Findings
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Measured: Baseline
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Measured: One Month
Number of Eyes With Stromal Edema - Slit Lamp Findings
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Measured: Baseline
Number of Eyes With Stromal Edema - Slit Lamp Findings
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Measured: One Month
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Measured: Baseline
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Measured: One Month
Number of Eyes With Corneal Staining - Slit Lamp Findings
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Measured: Baseline
Number of Eyes With Corneal Staining - Slit Lamp Findings
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Measured: One Month
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Corneal Infiltrates on slit lamp findings - Present / Absent
Measured: Baseline
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent
Measured: One Month
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Measured: Baseline
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Measured: One Month
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Measured: Baseline
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Measured: One Month
Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Measured: Baseline
Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Measured: One Month
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None
1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Measured: Baseline
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None
1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Measured: One Month

Secondary outcomes (1)

Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet
Measured: One Month

Timeline

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

10 Oct 20181 Jun 2019

First posted29 Oct 2018
Study start10 Oct 2018
Primary completion18 Jan 2019
Study completion1 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 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03722784
Sponsor's protocol ID: FC160322
Status last verified: Aug 2020
First submitted: 25 Oct 2018
Last updated: 1 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the CooperVision, Inc. Invigor A and Invigor B Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear
ClinicalTrials.gov ID: NCT03722784
Acronym / sponsor ID: FC160322
Conditions: Myopia, Hyperopia, Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 10 Oct 2018 (actual)
Primary completion: 18 Jan 2019 (actual)
Study completion: 1 Jun 2019 (actual)
First posted: 29 Oct 2018 (actual)
Results: Posted 1 Oct 2020

Clinical summary

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

The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.

Detailed description

Study design

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

Arm	Type	Receives
Invigor A (test)	Experimental	Device: Invigor A (test)Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study.
Invigor B (Control)	Active comparator	Device: Invigor B (control)Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Key exclusion criteria (12 listed)

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
Invigor A (test)silicone hydrogel lens	Device	Invigor A (test)
Invigor B (control)silicone hydrogel lens	Device	Invigor B (Control)

Primary outcome

Number of Eyes With Epithelial Edema - Slit Lamp Findings
Time frame: Baseline
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Time frame: One Month
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Number of Eyes With Stromal Edema - Slit Lamp Findings
Time frame: Baseline
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Number of Eyes With Stromal Edema - Slit Lamp Findings
Time frame: One Month
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Time frame: Baseline
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Time frame: One Month
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Number of Eyes With Corneal Staining - Slit Lamp Findings
Time frame: Baseline
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Number of Eyes With Corneal Staining - Slit Lamp Findings
Time frame: One Month
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Time frame: Baseline
Corneal Infiltrates on slit lamp findings - Present / Absent
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Time frame: One Month
Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Time frame: Baseline
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Time frame: One Month
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Time frame: Baseline
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Time frame: One Month
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
Time frame: Baseline
Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
Time frame: One Month
Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Time frame: Baseline
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Time frame: One Month
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe)

1 secondary outcome

Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
Time frame: One Month

Results and safety

Results posted to the registry on 1 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Invigor A (Test)	58	56
Invigor B (Control)	30	28

Primary outcome: Number of Eyes With Epithelial Edema - Slit Lamp Findings

Time frame: Baseline. Number. Unit: Eyes

Measure	Invigor A (Test) n = 56	Invigor B (Control) n = 28
Grade 0	112	56
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

Primary outcome: Number of Eyes With Epithelial Edema - Slit Lamp Findings

Time frame: One Month. Number. Unit: Eyes

Measure	Invigor A (Test) n = 55	Invigor B (Control) n = 27
Grade 0	110	54
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

Population analysed: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

Primary outcome: Number of Eyes With Stromal Edema - Slit Lamp Findings

Time frame: Baseline. Number. Unit: Eyes

Measure	Invigor A (Test) n = 56	Invigor B (Control) n = 28
Grade 0	112	56
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

Primary outcome: Number of Eyes With Stromal Edema - Slit Lamp Findings

Time frame: One Month. Number. Unit: Eyes

Measure	Invigor A (Test) n = 55	Invigor B (Control) n = 27
Grade 0	110	54
Grade 1	0	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

Population analysed: Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From dispense up to one month for each study lenses. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Invigor A (Test)	0 of 56 (0%)	0 of 56 (0%)	0 of 56
Invigor B (Control)	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
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.

Thomas Quinn, O.D principal investigator

Quinn, Foster & Associates, OH

Peter Van Hoven, O.D principal investigator

Primary Eyecare group, P.C, TN

Mark Nakano, O.D principal investigator

Mark Nakano, O.D, CA

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

Questions about this trial

What is this clinical trial studying?

A study testing Invigor A (test) in people with Myopia and Hyperopia, run by CooperVision, Inc. at 6 sites 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 10 inclusion and 12 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 1 Oct 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?

Number of Eyes With Epithelial Edema - Slit Lamp Findings (time frame: Baseline). The study lists 18 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 NCT03722784.

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 1 Oct 2020.