Contact Lens SolutionsNCT03632083
A Range of Contact Lenses and Care System Combinations
A study testing Hy-Care Contact Lens Solution, Lite Contact Lens Solution and fanfilcon A soft contact lens in people with Contact Lens Solutions, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Solutions
- What is being tested?
- Hy-Care Contact Lens Solution, Lite Contact Lens Solution and fanfilcon A soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Sep 2018to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are of legal age (18) and capacity to volunteer.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They agree not to participate in other clinical research for the duration of this study.
- They can be satisfactorily fitted with the study lens for a period of approximately 2 hours.
- They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with their habitual spectacles.
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- They currently wear daily disposable soft contact lenses or have done so in the previous six months.
- They are willing to comply with the wear schedule (approximately 2 hours on two different days)
- They own a wearable pair of spectacles and agree to bring these to study visits.
Who cannot join
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They currently wear reusable soft contact lenses in both eyes.
- They are using any topical medication such as eye drops or ointment.
- They have had cataract surgery.
- They have had corneal refractive surgery.
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- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or breast-feeding.
- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- They have Type 2 or greater corneal staining prior to lens application at Visit 1 or 2
- They have corneal staining covering greater than 20% in any corneal region at Visit 1a or 2a
- They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.
Read the detailed description
Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.
- Conditions
- Contact Lens Solutions
- Being tested
- Hy-Care Contact Lens Solution, Lite Contact Lens Solution, fanfilcon A soft contact lens, comfilcon A soft contact lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hy-Care Contact Lens SolutionDevice
Hy-Care Contact Lens Solution
Lite Contact Lens SolutionDevice
Lite Contact Lens Solution
fanfilcon A soft contact lensDevice
fanfilcon A soft contact lens
comfilcon A soft contact lensDevice
comfilcon A soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| Hy-Care Contact Lens Solution | Active comparator | Each subject will wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution. Receives: Device: Hy-Care Contact Lens Solution; Device: fanfilcon A soft contact lens; Device: comfilcon A soft contact lens |
| Lite Contact Lens Solution | Active comparator | Each subject will wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Lite contact lens solution. Receives: Device: Lite Contact Lens Solution; Device: fanfilcon A soft contact lens; Device: comfilcon A soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomicroscopy - Conjuctival Hyperaemia
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: Baseline (before lens insertion)
Biomicroscopy - Conjuctival Hyperaemia
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 2 hours
Biomicroscopy - Limbal Hyperaemia
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: Baseline (before contact lens insertion)
Biomicroscopy - Limbal Hyperaemia
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 2 hours
Biomicroscopy - Corneal Vascularisation
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: Baseline (before lens insertion)
Biomicroscopy - Corneal Vascularisation
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 2 hours
Biomicroscopy - Microcysts
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: Baseline (before lens insertion)
Biomicroscopy - Microcysts
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 2 hours
Biomicroscopy - Oedema
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: Baseline (before lens insertion)
Biomicroscopy - Oedema
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 2 hours
Biomicroscopy - Conjunctival Staining
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: Baseline (before lens insertion)
Biomicroscopy - Conjunctival Staining
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 2 hours
Biomicroscopy - Papillary Conjunctivitis
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: Baseline (before lens insertion)
Biomicroscopy - Papillary Conjunctivitis
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 2 hours
Secondary outcomes (5)
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Measured: Baseline 5 minutes after lens insertion
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Measured: 2 hours
Dryness
Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness).
Measured: 2 hours
Overall Score
Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Measured: Baseline 5 minutes after lens insertion
Overall Score
Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start12 Sep 2018
- Primary completion23 Oct 2018
- Study completion12 Dec 2018
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 Contact Lens SolutionsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Morgan, PhD MCOptom FAAO FBCLA, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632083
- Sponsor's protocol ID
- C17-635 (EX-MKTG-95)
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2018
- Last updated
- 24 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Range of Contact Lenses and Care System Combinations
- ClinicalTrials.gov ID
- NCT03632083
- Acronym / sponsor ID
- C17-635 (EX-MKTG-95)
- Conditions
- Contact Lens Solutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.
Detailed description
Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.
| Arm | Type | Receives |
|---|---|---|
| Hy-Care Contact Lens Solution | Active comparator | Device: Hy-Care Contact Lens Solution, Device: fanfilcon A soft contact lens, Device: comfilcon A soft contact lensEach subject will wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution. |
| Lite Contact Lens Solution | Active comparator | Device: Lite Contact Lens Solution, Device: fanfilcon A soft contact lens, Device: comfilcon A soft contact lensEach subject will wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Lite contact lens solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- They are of legal age (18) and capacity to volunteer.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They agree not to participate in other clinical research for the duration of this study.
- They can be satisfactorily fitted with the study lens for a period of approximately 2 hours.
Key exclusion criteria (13 listed)
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They currently wear reusable soft contact lenses in both eyes.
- They are using any topical medication such as eye drops or ointment.
- They have had cataract surgery.
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 |
|---|---|---|
| Hy-Care Contact Lens SolutionHy-Care Contact Lens Solution | Device | Hy-Care Contact Lens Solution |
| Lite Contact Lens SolutionLite Contact Lens Solution | Device | Lite Contact Lens Solution |
| fanfilcon A soft contact lensfanfilcon A soft contact lens | Device | Hy-Care Contact Lens Solution, Lite Contact Lens Solution |
| comfilcon A soft contact lenscomfilcon A soft contact lens | Device | Hy-Care Contact Lens Solution, Lite Contact Lens Solution |
Primary outcome
Biomicroscopy - Conjuctival Hyperaemia
Time frame: Baseline (before lens insertion)
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Conjuctival Hyperaemia
Time frame: 2 hours
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Limbal Hyperaemia
Time frame: Baseline (before contact lens insertion)
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Limbal Hyperaemia
Time frame: 2 hours
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Corneal Vascularisation
Time frame: Baseline (before lens insertion)
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Corneal Vascularisation
Time frame: 2 hours
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Microcysts
Time frame: Baseline (before lens insertion)
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Microcysts
Time frame: 2 hours
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Oedema
Time frame: Baseline (before lens insertion)
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Oedema
Time frame: 2 hours
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Conjunctival Staining
Time frame: Baseline (before lens insertion)
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Conjunctival Staining
Time frame: 2 hours
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Papillary Conjunctivitis
Time frame: Baseline (before lens insertion)
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Biomicroscopy - Papillary Conjunctivitis
Time frame: 2 hours
Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
5 secondary outcomes
Comfort
Time frame: Baseline 5 minutes after lens insertion
Comfort
Time frame: 2 hours
Dryness
Time frame: 2 hours
Overall Score
Time frame: Baseline 5 minutes after lens insertion
Overall Score
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
Philip Morgan, PhD MCOptom FAAO FBCLA principal investigator
Eurolens Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hy-Care Contact Lens Solution, Lite Contact Lens Solution and fanfilcon A soft contact lens in people with Contact Lens Solutions, run by CooperVision, Inc. at 1 site in United Kingdom.
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 9 inclusion and 13 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 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 24 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomicroscopy - Conjuctival Hyperaemia (time frame: Baseline (before lens insertion)). The study lists 14 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 24 Aug 2020.