MyopiaNCT05438615
Corneal Refractive Therapy Design Comparison for -4 to -6 Diopter Treatment for Overnight Wear for Myopia
A study testing Corneal Refractive Therapy-spherical and Corneal Refractive Therapy-aspherical in people with Myopia, run by CooperVision International Limited (CVIL) at 1 site in United States.
Trial summary
The primary objective of this study is to compare the effectiveness of two proximity control geometry lens designs to treat eyes with pretreatment myopia between -4.00 and -6.00 D myopia with and without refractive astigmatism in a modality involving overnight wearing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Corneal Refractive Therapy-spherical and Corneal Refractive Therapy-aspherical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 27 Oct 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
- The prospective eye(s) must have naturally occurring refractive myopia from -4.00 to -6.00 diopters sphere (spectacle plane), with up to -1.75 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
- Patients must have best spectacle corrected visual acuity of at least 0.04 logMAR in each eye.
- If the Subject wears rigid contact lenses in the prospective eye(s), lens use must cease at least four (4) weeks prior to the pre-treatment examination. The subject must have two central keratometry readings taken that are at least one week apart. The two readings shall not differ by more than 0.50 diopter in either meridian. The mires should be regular.
- Patients must be willing and capable to return for all scheduled follow-up visits for a period of at least 6 months.
Who cannot join
- Female patients who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
- Patients with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, shall specifically exclude patients from eligibility.
- Patients with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization >1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring).
- Note: This includes any Subject with open angle glaucoma, regardless of medication regimen or control. Additionally, any Subject with an intraocular greater than 21 mm Hg at baseline is specifically excluded from eligibility.
- Patients with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- Patients with pupil size greater than 5.5 mm in photopic illumination as measured with infrared pupillometry, pupil detection component of computer assisted video keratography, or slit lamp reticule.
- Patients who are participating in any other clinical trial (FDA or other).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
Official title: A Prospective Study to Compare Lenses Having Two Different Proximity Control Designs for Overnight Wear for Treatment of Naturally Occurring Myopia From -4 to -6 Diopters Sphere With Refractive Astigmatism up to -1.75 Diopters
The primary objective of this study is to compare the effectiveness of two proximity control geometry lens designs to treat eyes with pretreatment myopia between -4.00 and -6.00 D myopia with and without refractive astigmatism in a modality involving overnight wearing.
Read the detailed description
Each subject shall undergo a comprehensive eye examination to determine eligibility. Subjects must meet all eligibility criteria. All eyes shall be treated with two pair of the proximity control lenses by the qualified clinical investigator. The first pair shall be dispensed and scheduled follow-up examinations shall be conducted at one day, one week, and two weeks after dispensing lenses. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. The second design shall be dispensed and scheduled follow-up examinations shall be conducted at one day, one week, and two weeks after dispensing lenses. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure.
- Conditions
- Myopia
- Being tested
- Corneal Refractive Therapy-spherical, Corneal Refractive Therapy-aspherical
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Refractive Therapy-sphericalOther
A comparison of two different designs of Corneal Refractive Therapy contact lenses will be done. Each will be worn for two weeks. The sponsor will mask which lens will be first or second in the trial.
Corneal Refractive Therapy-asphericalOther
A comparison of two different designs of Corneal Refractive Therapy contact lenses will be done. Each will be worn for two weeks. The sponsor will mask which lens will be first or second in the trial.
| Study group | Role | What they receive |
|---|---|---|
| Corneal Refractive Therapy - spherical | Experimental | Subjects eyes shall be treated with two pair of the proximity control lenses in Paragon paflufocon D material by the qualified clinical investigator. The subjects shall be randomized for which of the two designs are applied first. The first pair shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. The second design shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. Receives: Other: Corneal Refractive Therapy-spherical |
| Corneal Refractive Therapy - aspherical | Experimental | Subjects eyes shall be treated with two pair of the proximity control lenses in Paragon paflufocon D material by the qualified clinical investigator. The subjects shall be randomized for which of the two designs are applied first. The first pair shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. The second design shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. Receives: Other: Corneal Refractive Therapy-aspherical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refraction
Measured: Two weeks after successful fitting of each lens
visual acuity
Measured: Two weeks after successful fitting of each lens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study startDec 2015
- Primary completion27 Oct 2016
- Study completion27 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph T Barr, OD MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438615
- Sponsor's protocol ID
- 2015W0189
- Status last verified
- Jul 2022
- First submitted
- 17 Dec 2015
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Compare Lenses Having Two Different Proximity Control Designs for Overnight Wear for Treatment of Naturally Occurring Myopia From -4 to -6 Diopters Sphere With Refractive Astigmatism up to -1.75 Diopters
- ClinicalTrials.gov ID
- NCT05438615
- Acronym / sponsor ID
- 2015W0189
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 27 Oct 2016 (actual)
- Study completion
- 27 Oct 2016 (actual)
- First posted
- 30 Jun 2022 (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 compare the effectiveness of two proximity control geometry lens designs to treat eyes with pretreatment myopia between -4.00 and -6.00 D myopia with and without refractive astigmatism in a modality involving overnight wearing.
Detailed description
Each subject shall undergo a comprehensive eye examination to determine eligibility. Subjects must meet all eligibility criteria. All eyes shall be treated with two pair of the proximity control lenses by the qualified clinical investigator. The first pair shall be dispensed and scheduled follow-up examinations shall be conducted at one day, one week, and two weeks after dispensing lenses. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. The second design shall be dispensed and scheduled follow-up examinations shall be conducted at one day, one week, and two weeks after dispensing lenses. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal Refractive Therapy - spherical | Experimental | Other: Corneal Refractive Therapy-sphericalSubjects eyes shall be treated with two pair of the proximity control lenses in Paragon paflufocon D material by the qualified clinical investigator. The subjects shall be randomized for which of the two designs are applied first. The first pair shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. The second design shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. |
| Corneal Refractive Therapy - aspherical | Experimental | Other: Corneal Refractive Therapy-asphericalSubjects eyes shall be treated with two pair of the proximity control lenses in Paragon paflufocon D material by the qualified clinical investigator. The subjects shall be randomized for which of the two designs are applied first. The first pair shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. The second design shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks. Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
- The prospective eye(s) must have naturally occurring refractive myopia from -4.00 to -6.00 diopters sphere (spectacle plane), with up to -1.75 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
- Patients must have best spectacle corrected visual acuity of at least 0.04 logMAR in each eye.
- If the Subject wears rigid contact lenses in the prospective eye(s), lens use must cease at least four (4) weeks prior to the pre-treatment examination. The subject must have two central keratometry readings taken that are at least one week apart. The two readings shall not differ by more than 0.50 diopter in either meridian. The mires should be regular.
- Patients must be willing and capable to return for all scheduled follow-up visits for a period of at least 6 months.
Key exclusion criteria (8 listed)
- Female patients who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
- Patients with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, shall specifically exclude patients from eligibility.
- Patients with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization >1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring).
- Note: This includes any Subject with open angle glaucoma, regardless of medication regimen or control. Additionally, any Subject with an intraocular greater than 21 mm Hg at baseline is specifically excluded from eligibility.
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 |
|---|---|---|
| Corneal Refractive Therapy-sphericalA comparison of two different designs of Corneal Refractive Therapy contact lenses will be done. Each will be worn for two weeks. The sponsor will mask which lens will be first or second in the trial. | Other | Corneal Refractive Therapy - spherical |
| Corneal Refractive Therapy-asphericalA comparison of two different designs of Corneal Refractive Therapy contact lenses will be done. Each will be worn for two weeks. The sponsor will mask which lens will be first or second in the trial. | Other | Corneal Refractive Therapy - aspherical |
Primary outcome
Refraction
Time frame: Two weeks after successful fitting of each lens
visual acuity
Time frame: Two weeks after successful fitting of each lens
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 20 Jan 2026.
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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.
Joseph T Barr, OD MS principal investigator
Ohio State 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 Corneal Refractive Therapy-spherical and Corneal Refractive Therapy-aspherical in people with Myopia, run by CooperVision International Limited (CVIL) 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 5 inclusion and 8 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 20 Jan 2026. 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?
Refraction (time frame: Two weeks after successful fitting of each lens). The study lists 2 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 20 Jan 2026.