PresbyopiaNCT03653715
Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss
A study testing Clerio Vision LIRIC-modified Bifocal Contact Lens, Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens and Johnson & Johnson 1-Day Acuvue Moist Contact Lens in people with Presbyopia, run by Clerio Vision, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the distance, intermediate and near visual performance of Clerio designed single vision and Clerio designed LIRIC modified bifocal lenses (+2.00D add) compared to commercially available single vision and multifocal lenses. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Clerio Vision LIRIC-modified Bifocal Contact Lens, Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens and Johnson & Johnson 1-Day Acuvue Moist Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 12 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Legal age (at least 21) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
- Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
- Willing and able to comply with all study instructions/procedures.
- Best Distance Spherical Corrected Visual Acuity (BDSCVA) in at least one eye of 20/25 (0.10 logMAR).
- Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Previous experience with contact lenses.
Show all 10Show fewer
- Distance spectacle spherical correction in at least one eye within +/- 5D of the study lens power (-3.00D).
- Habitual spectacle addition (at 40cm) of at least +1.00D.
- Refractive astigmatism less than -2.75D.
- Most recent complete eye examination was within the last 24 months of the date of study completion.
Who cannot join
- Currently participating in any drug or device clinical investigation during the period of study participation.
- Active anterior segment ocular disease or using any ocular medication for anterior segment disease (e.g. conjunctivitis, dry-eye disease).
- Current or past condition that might have caused corneal distortion or anterior surface topography abnormalities (e.g. keratoconus, map-dot fingerprint or any other corneal dystrophies, corneal disease or trauma resulting in scarring, pterygium, pellucid marginal degeneration)
- Previous refractive corneal surgery (e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), corneal transplant, Descemet's Stripping Endothelial Keratoplasty (DSEK) etc.).
- Considered by the Investigator to not be a suitable candidate for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clerio Vision Research Clinic
Rochester, New York, 14607
About this study
Official title: Clinical Performance Study of Clerio Single Vision and Bifocal Contact Lens Designs Immediately Following Insertion
The primary objective of this study is to evaluate the distance, intermediate and near visual performance of Clerio designed single vision and Clerio designed LIRIC modified bifocal lenses (+2.00D add) compared to commercially available single vision and multifocal lenses.
Read the detailed description
Clerio Vision Inc. has licensed a new femtosecond based laser procedure discovered by researchers at the University of Rochester known as Laser Induced Refractive Index Customization (LIRIC), which allows the alteration of the optical design of a finished soft hydrogel contact lens. Clerio Vision Inc. scientists have developed a diffractive multifocal optical design using the LIRIC procedure which shows an increase of the depth of focus of the contact lens when measured on an optical bench. It is hypothesized that a presbyopic patient wearing a soft contact lens of this design will experience an improvement in intermediate and near vision over that provided by their distance corrected single vision contact lenses, without significantly impacting their distance vision. The purpose of this feasibility study is the on-eye evaluation of the performance of the Clerio Vision designed and LIRIC modified soft contact lenses. Results from this study will guide future development of these potential products.
- Conditions
- Presbyopia
- Being tested
- Clerio Vision LIRIC-modified Bifocal Contact Lens, Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Johnson & Johnson 1-Day Acuvue Moist Contact Lens, Clerio Vision Single Vision Contact Lens
- Keywords
- Refractive Errors, Myopia, Hyperopia, Astigmatism
- Medical subject headings
- Presbyopia, Refractive Errors, Myopia, Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clerio Vision LIRIC-modified Bifocal Contact LensDevice
Also called Clerio Vision Bifocal Contact Lens, Clerio Vision Multifocal Contact Lens, Laser-Induced Refractive Index Change (LIRIC) Bifocal Contact Lens
Within this arm the investigational acofilcon B material bifocal contact lens, which has been modified with the laser and is the focus of the study, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact LensDevice
Also called Commercially Available Multifocal Contact Lens, Control Multifocal Contact Lens, Etafilcon A
Within this arm the control etafilcon A material bifocal contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
Johnson & Johnson 1-Day Acuvue Moist Contact LensDevice
Also called Commercially Available Single Vision Contact Lens, Control Single Vision Contact Lens, Etafilcon A
Within this arm the control etafilcon A material single vision contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
Clerio Vision Single Vision Contact LensDevice
Also called Contamac 49 Single Vision Contact Lens, Control Single Vision Contact Lens, Acofilcon B
Within this arm the control acofilcon B material single vision contact lens, the material of which is commercially available from Contamac Ltd, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Test Device | Experimental | Within this arm the Clerio Vision LIRIC-modified Bifocal Contact Lens is administered. Receives: Device: Clerio Vision LIRIC-modified Bifocal Contact Lens |
| Control Devices | Active comparator | Within this arm the Johnson \& Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Johnson \& Johnson 1-Day Acuvue Moist Contact Lens, and Clerio Vision Single Vision Contact Lens are administered. Receives: Device: Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens; Device: Johnson & Johnson 1-Day Acuvue Moist Contact Lens; Device: Clerio Vision Single Vision Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Through-Focus High Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2
Visual acuity is measured under high contrast conditions (85% contrast relative to the chart background) at object testing distances of 5.3m, 2m, 1m, 67cm, 50cm and 40cm ("through-focus"), recorded in units of logMAR.
Measured: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Secondary outcomes (3)
Comparison of Through-Focus Low Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2
Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 5.3m, 2m, 1m, 67cm, 50cm and 40cm ("through-focus"), recorded in units of logMAR.
Measured: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Comparison of Visual Quality for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2
Visual quality is a subjective rating that a participant chooses using an analog rating chart ranging from 0 to 100. Participants are asked to look at the letters that they can read, not the ones that they can't, and rate how sharp those letters are, with 0 denoting "unacceptable" and 100 denoting "excellent." They are asked to reduce their score if any halos, glare, or double vision are present.
Measured: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Comparison of Fitting Performance for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2
Fitting performance is measured by visual observation of the contact lens on a participant's eye using a slit lamp biomicroscope and ocular measurement reticle. The position of the lens edge relative to the corneal boundaries both immediately before and immediately after a blink is measured.
Measured: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start6 Aug 2018
- Primary completion27 Aug 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies 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
- Model description
- This single center study is a device feasibility, two-arm, double-masked (participants and outcomes assessor), repeated measures, cross-sectional design. Each participant is tested with the four (4) study devices (i.e., contact lenses), one (1) test lens and three (3) control lenses, in randomized order. Participants are masked to each lens they wear.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clerio Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Lagana, OD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653715
- Sponsor's protocol ID
- CVR-18-001
- Status last verified
- Apr 2019
- First submitted
- 27 Aug 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ding L, Blackwell R, Kunzler JF, Knox WH. Large refractive index change in silicone-based and non-silicone-based hydrogel polymers induced by femtosecond laser micro-machining. Opt Express. 2006 Nov 27;14(24):11901-9. doi: 10.1364/oe.14.011901.
PubMed 19529613Ding L, Knox WH, Buhren J, Nagy LJ, Huxlin KR. Intratissue refractive index shaping (IRIS) of the cornea and lens using a low-pulse-energy femtosecond laser oscillator. Invest Ophthalmol Vis Sci. 2008 Dec;49(12):5332-9. doi: 10.1167/iovs.08-1921. Epub 2008 Jul 18.
PubMed 18641284Xu L, Knox WH, DeMagistris M, Wang N, Huxlin KR. Noninvasive intratissue refractive index shaping (IRIS) of the cornea with blue femtosecond laser light. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8148-55. doi: 10.1167/iovs.11-7323.
PubMed 21931133Savage DE, Brooks DR, DeMagistris M, Xu L, MacRae S, Ellis JD, Knox WH, Huxlin KR. First demonstration of ocular refractive change using blue-IRIS in live cats. Invest Ophthalmol Vis Sci. 2014 Jul 1;55(7):4603-12. doi: 10.1167/iovs.14-14373.
PubMed 24985471Wozniak KT, Elkins N, Brooks DR, Savage DE, MacRae S, Ellis JD, Knox WH, Huxlin KR. Contrasting cellular damage after Blue-IRIS and Femto-LASIK in cat cornea. Exp Eye Res. 2017 Dec;165:20-28. doi: 10.1016/j.exer.2017.08.018. Epub 2017 Aug 31.
PubMed 28866013
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Study of Clerio Single Vision and Bifocal Contact Lens Designs Immediately Following Insertion
- ClinicalTrials.gov ID
- NCT03653715
- Acronym / sponsor ID
- CVR-18-001
- Conditions
- Presbyopia
- Keywords
- Refractive Errors, Myopia, Hyperopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clerio Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
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 this study is to evaluate the distance, intermediate and near visual performance of Clerio designed single vision and Clerio designed LIRIC modified bifocal lenses (+2.00D add) compared to commercially available single vision and multifocal lenses.
Detailed description
Clerio Vision Inc. has licensed a new femtosecond based laser procedure discovered by researchers at the University of Rochester known as Laser Induced Refractive Index Customization (LIRIC), which allows the alteration of the optical design of a finished soft hydrogel contact lens. Clerio Vision Inc. scientists have developed a diffractive multifocal optical design using the LIRIC procedure which shows an increase of the depth of focus of the contact lens when measured on an optical bench. It is hypothesized that a presbyopic patient wearing a soft contact lens of this design will experience an improvement in intermediate and near vision over that provided by their distance corrected single vision contact lenses, without significantly impacting their distance vision. The purpose of this feasibility study is the on-eye evaluation of the performance of the Clerio Vision designed and LIRIC modified soft contact lenses. Results from this study will guide future development of these potential products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This single center study is a device feasibility, two-arm, double-masked (participants and outcomes assessor), repeated measures, cross-sectional design. Each participant is tested with the four (4) study devices (i.e., contact lenses), one (1) test lens and three (3) control lenses, in randomized order. Participants are masked to each lens they wear.
| Arm | Type | Receives |
|---|---|---|
| Test Device | Experimental | Device: Clerio Vision LIRIC-modified Bifocal Contact LensWithin this arm the Clerio Vision LIRIC-modified Bifocal Contact Lens is administered. |
| Control Devices | Active comparator | Device: Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Device: Johnson & Johnson 1-Day Acuvue Moist Contact Lens, Device: Clerio Vision Single Vision Contact LensWithin this arm the Johnson \& Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Johnson \& Johnson 1-Day Acuvue Moist Contact Lens, and Clerio Vision Single Vision Contact Lens are administered. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Legal age (at least 21) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
- Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
- Willing and able to comply with all study instructions/procedures.
- Best Distance Spherical Corrected Visual Acuity (BDSCVA) in at least one eye of 20/25 (0.10 logMAR).
- Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Key exclusion criteria (5 listed)
- Currently participating in any drug or device clinical investigation during the period of study participation.
- Active anterior segment ocular disease or using any ocular medication for anterior segment disease (e.g. conjunctivitis, dry-eye disease).
- Current or past condition that might have caused corneal distortion or anterior surface topography abnormalities (e.g. keratoconus, map-dot fingerprint or any other corneal dystrophies, corneal disease or trauma resulting in scarring, pterygium, pellucid marginal degeneration)
- Previous refractive corneal surgery (e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), corneal transplant, Descemet's Stripping Endothelial Keratoplasty (DSEK) etc.).
- Considered by the Investigator to not be a suitable candidate for participation.
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 |
|---|---|---|
| Clerio Vision LIRIC-modified Bifocal Contact LensAlso: Clerio Vision Bifocal Contact Lens, Clerio Vision Multifocal Contact Lens, Laser-Induced Refractive Index Change (LIRIC) Bifocal Contact LensWithin this arm the investigational acofilcon B material bifocal contact lens, which has been modified with the laser and is the focus of the study, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes. | Device | Test Device |
| Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact LensAlso: Commercially Available Multifocal Contact Lens, Control Multifocal Contact Lens, Etafilcon AWithin this arm the control etafilcon A material bifocal contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes. | Device | Control Devices |
| Johnson & Johnson 1-Day Acuvue Moist Contact LensAlso: Commercially Available Single Vision Contact Lens, Control Single Vision Contact Lens, Etafilcon AWithin this arm the control etafilcon A material single vision contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes. | Device | Control Devices |
| Clerio Vision Single Vision Contact LensAlso: Contamac 49 Single Vision Contact Lens, Control Single Vision Contact Lens, Acofilcon BWithin this arm the control acofilcon B material single vision contact lens, the material of which is commercially available from Contamac Ltd, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes. | Device | Control Devices |
Primary outcome
Comparison of Through-Focus High Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2
Time frame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Visual acuity is measured under high contrast conditions (85% contrast relative to the chart background) at object testing distances of 5.3m, 2m, 1m, 67cm, 50cm and 40cm ("through-focus"), recorded in units of logMAR.
3 secondary outcomes
Comparison of Through-Focus Low Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2
Time frame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Comparison of Visual Quality for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2
Time frame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Comparison of Fitting Performance for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2
Time frame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: PubMed 19529613Ding L, Blackwell R, Kunzler JF, Knox WH. Large refractive index change in silicone-based and non-silicone-based hydrogel polymers induced by femtosecond laser micro-machining. Opt Express. 2006 Nov 27;14(24):11901-9. doi: 10.1364/oe.14.011901.
- Background: PubMed 18641284Ding L, Knox WH, Buhren J, Nagy LJ, Huxlin KR. Intratissue refractive index shaping (IRIS) of the cornea and lens using a low-pulse-energy femtosecond laser oscillator. Invest Ophthalmol Vis Sci. 2008 Dec;49(12):5332-9. doi: 10.1167/iovs.08-1921. Epub 2008 Jul 18.
- Background: PubMed 21931133Xu L, Knox WH, DeMagistris M, Wang N, Huxlin KR. Noninvasive intratissue refractive index shaping (IRIS) of the cornea with blue femtosecond laser light. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8148-55. doi: 10.1167/iovs.11-7323.
- Background: PubMed 24985471Savage DE, Brooks DR, DeMagistris M, Xu L, MacRae S, Ellis JD, Knox WH, Huxlin KR. First demonstration of ocular refractive change using blue-IRIS in live cats. Invest Ophthalmol Vis Sci. 2014 Jul 1;55(7):4603-12. doi: 10.1167/iovs.14-14373.
- Background: PubMed 28866013Wozniak KT, Elkins N, Brooks DR, Savage DE, MacRae S, Ellis JD, Knox WH, Huxlin KR. Contrasting cellular damage after Blue-IRIS and Femto-LASIK in cat cornea. Exp Eye Res. 2017 Dec;165:20-28. doi: 10.1016/j.exer.2017.08.018. Epub 2017 Aug 31.
- 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.
Michele Lagana, OD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clerio Vision LIRIC-modified Bifocal Contact Lens, Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens and Johnson & Johnson 1-Day Acuvue Moist Contact Lens in people with Presbyopia, run by Clerio Vision, 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 10 inclusion and 5 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 19 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of Through-Focus High Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2 (time frame: starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)). 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 NCT03653715, which also lists 5 linked publications.
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 19 Apr 2019.