MyopiaNCT03278223
One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
A study testing Test solution in people with Myopia and Hyperopia, run by OTE North America at 11 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the clinical performance of the contact lens care product Oté Sensation in a representative population of soft contact lens wearers. For comparison, a widely used FDA approved soft lens multipurpose solution will be used as a control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Test solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 14 Aug 2017to 20 Dec 2017
- 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 a currently adapted soft contact lens wearer (>1 month of lens wear).
- Be at least 18 years of age.
- Refractive astigmatism <0.75 D in both eyes.
- Have clear corneas and be free of any anterior segment disorders.
- Be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 LogMAR) or better in each eye.
- Contact lens sphere requirement between +4.00 Dioptre and -8.00 D (inclusive).
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- Require visual correction in both eyes (monovision allowed, no monofit).
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia
- No strabismus
- No evidence of lid abnormality or infection
- No conjunctival abnormality or infection that would contraindicate contact lens wear
- No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
- No other active ocular disease.
Who cannot join
- Require toric or multifocal contact lenses.
- Previously shown a sensitivity to any of the study solution components.
- Any systemic or ocular disease or allergies affecting ocular health.
- Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
- Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
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- Keratoconus or other corneal irregularity.
- Aphakia or amblyopia.
- Have undergone corneal refractive surgery or any anterior segment surgery.
- Abnormal lacrimal secretions.
- Has diabetes.
- Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- History of chronic eye disease (e.g. glaucoma).
- Pregnant or lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or in last 30 days.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United Kingdom6 sites
Brock and Houlford
Chew Magna, Bristol, BS40 8PR
First Contact
Eastcote, Pinner, HA5 1RJ
Visioncare Research Ltd
Farnham, Surrey, GU9 7EN
Leightons and Tempany
Poole, Bournemouth, BH15 1AU
Eyesite
Reading, Berkshire, RG1 1EX
Harrold Opticians
Uxbridge, Middlesex, UB8 1JX
United States5 sites
Optometry Group PLLC
Memphis, Tennessee, 38111
Kannarr Eye Care
Pittsburg, Kansas, 66762
Golden Vision
Sarasota, Florida, 34232
Frazier Vision, Inc.
Tyler, Texas, 75703
Sacco Eye Group
Vestal, New York, 13850
About this study
The purpose of this study is to evaluate the clinical performance of the contact lens care product Oté Sensation in a representative population of soft contact lens wearers. For comparison, a widely used FDA approved soft lens multipurpose solution will be used as a control. This control product has been tested in previous clinical trials.
Read the detailed description
This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized, comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit 1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of six lens types and to either the test or control solutions.
- Being tested
- Test solution, Control solution
- Keywords
- Multipurpose Contact Lens Care System
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test solutionDevice
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
Control solutionDevice
A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
| Study group | Role | What they receive |
|---|---|---|
| Test solution | Active comparator | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. Receives: Device: Test solution |
| Control solution | Active comparator | A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. Receives: Device: Control solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
Measured: Up to 4 weeks
Visual Acuity (VA)
Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of three meters from the eye chart and asked to start reading letters from the top line and to continuing reading letters until they are unable to correctly identify three letters on any given line. The Visual Acuity was recorded to the nearest letter.
Measured: Visual Acuity was assessed for all participants after 2 weeks from day of dispensing lens solution and then again at the final evaluation at the 1 month visit.
Lens Surface Wetting
Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)
Measured: Up to 4 weeks
Film Deposits
Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)
Measured: Up to 4 weeks
Corneal Staining
Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.
Measured: Up to 4 weeks
Limbal Hyperemia
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Measured: Up to 4 weeks
Bulbar Hyperemia
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start14 Aug 2017
- Primary completion17 Nov 2017
- Study completion20 Dec 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- OTE North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor
- Investigators
- Frances L Nicklin, Bsc, MCOptom, Principal investigator, Visioncare Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278223
- Sponsor's protocol ID
- OTES-3301
- Status last verified
- Mar 2021
- First submitted
- 8 Sep 2017
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
- ClinicalTrials.gov ID
- NCT03278223
- Acronym / sponsor ID
- OTES-3301
- Keywords
- Multipurpose Contact Lens Care System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- OTE North AmericaIndustry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Posted 26 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical performance of the contact lens care product Oté Sensation in a representative population of soft contact lens wearers. For comparison, a widely used FDA approved soft lens multipurpose solution will be used as a control. This control product has been tested in previous clinical trials.
Detailed description
This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized, comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit 1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of six lens types and to either the test or control solutions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test solution | Active comparator | Device: Test solutionA Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. |
| Control solution | Active comparator | Device: Control solutionA Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be a currently adapted soft contact lens wearer (>1 month of lens wear).
- Be at least 18 years of age.
- Refractive astigmatism <0.75 D in both eyes.
- Have clear corneas and be free of any anterior segment disorders.
- Be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 LogMAR) or better in each eye.
Key exclusion criteria (15 listed)
- Require toric or multifocal contact lenses.
- Previously shown a sensitivity to any of the study solution components.
- Any systemic or ocular disease or allergies affecting ocular health.
- Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
- Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
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 |
|---|---|---|
| Test solutionA Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2. | Device | Test solution |
| Control solutionA Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1. | Device | Control solution |
Primary outcome
Comfort
Time frame: Up to 4 weeks
Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
Visual Acuity (VA)
Time frame: Visual Acuity was assessed for all participants after 2 weeks from day of dispensing lens solution and then again at the final evaluation at the 1 month visit.
Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of three meters from the eye chart and asked to start reading letters from the top line and to continuing reading letters until they are unable to correctly identify three letters on any given line. The Visual Acuity was recorded to the nearest letter.
Lens Surface Wetting
Time frame: Up to 4 weeks
Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)
Film Deposits
Time frame: Up to 4 weeks
Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)
Corneal Staining
Time frame: Up to 4 weeks
Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.
Limbal Hyperemia
Time frame: Up to 4 weeks
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Bulbar Hyperemia
Time frame: Up to 4 weeks
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- 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.
Frances L Nicklin, Bsc, MCOptom principal investigator
Visioncare Research Ltd.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test solution in people with Myopia and Hyperopia, run by OTE North America at 11 sites in 2 countries.
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 14 inclusion and 15 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 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, 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 26 Mar 2021). 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?
Comfort (time frame: Up to 4 weeks). The study lists 7 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 26 Mar 2021.