Contact Lens SolutionsNCT01791517
Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions
A study testing Solution 1 (Test), Solution 2 (Test) and Solution 3 (Test) in people with Contact Lens Solutions, run by Johnson & Johnson Vision Care, Inc. at 3 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution). Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Solutions
- What is being tested?
- Solution 1 (Test), Solution 2 (Test) and Solution 3 (Test)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Feb 2013to 1 Feb 2014
- 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol.
- The subject must be between 18 and 69 years of age.
- The subject must be willing to participate in a 9-month study.
- The subject must require a visual correction in both eyes.
- Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.
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- The subject must have best-corrected visual acuity of 0.20 or better in each eye.
- The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
- The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.
- The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
Who cannot join
- Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).
- Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
- Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
- Any active ocular infection.
- Current use of topical ophthalmic medications.
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- History of binocular vision abnormality or strabismus.
- More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
- History of severe allergic reaction or anaphylaxis.
- Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
- Employee of the investigational clinic (e.g. investigator, coordinator, technician)
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of Houston College of Optometry
Houston, Texas, 77204
Canada1 site
University of Waterloo Centre for Contact Lens Research School of Optometry
Waterloo, Ontario
United Kingdom1 site
University of Manchester, Department of Optometry & Neuroscience
Manchester, Lancashire
About this study
Official title: Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions
The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).
- Conditions
- Contact Lens Solutions
- Being tested
- Solution 1 (Test), Solution 2 (Test), Solution 3 (Test), Solution 4 (Control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution 1 (Test)Other
Also called Revitalens
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Solution 2 (Test)Other
Also called Pure Moist
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Solution 3 (Test)Other
Also called Biotrue
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Solution 4 (Control)Other
Also called Clear Care
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
| Study group | Role | What they receive |
|---|---|---|
| Lens A (senofilcon A) | Other | Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). Receives: Other: Solution 1 (Test); Other: Solution 2 (Test); Other: Solution 3 (Test); Other: Solution 4 (Control) |
| Lens B (galyfilcon A) | Other | Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). Receives: Other: Solution 1 (Test); Other: Solution 2 (Test); Other: Solution 3 (Test); Other: Solution 4 (Control) |
| Lens C (etafilcon A) | Other | Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). Receives: Other: Solution 1 (Test); Other: Solution 2 (Test); Other: Solution 3 (Test); Other: Solution 4 (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Comfort Score (Senofilcon A Lens)
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Measured: 2-Week Follow-up
Overall Comfort Score (Galyfilcon A Lens)
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Measured: 2-Week Follow-up
Overall Comfort Score (Etafilcon A Lens)
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Measured: 2-Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start1 Feb 2013
- Primary completion1 Feb 2014
- Study completion1 Feb 2014
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791517
- Sponsor's protocol ID
- CR-5230
- Status last verified
- Oct 2017
- First submitted
- 11 Feb 2013
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schulze MM, Srinivasan S, Hickson-Curran SB, Berntsen DA, Howarth GF, Toubouti Y, Morgan P, Nichols JJ, Jones LW; Performance of Contact Lens Solutions Study Group. Lid Wiper Epitheliopathy in Soft Contact Lens Wearers. Optom Vis Sci. 2016 Aug;93(8):943-54. doi: 10.1097/OPX.0000000000000919.
PubMed 27391533Berntsen DA, Hickson-Curran SB, Jones LW, Mathew JH, Maldonado-Codina C, Morgan PB, Schulze MM, Nichols JJ; Performance of Contact Lens Solutions Study Group. Subjective Comfort and Physiology with Modern Contact Lens Care Products. Optom Vis Sci. 2016 Aug;93(8):809-19. doi: 10.1097/OPX.0000000000000901.
PubMed 27309523
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions
- ClinicalTrials.gov ID
- NCT01791517
- Acronym / sponsor ID
- CR-5230
- Conditions
- Contact Lens Solutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 1 Feb 2014 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Posted 6 Nov 2017
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 and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lens A (senofilcon A) | Other | Other: Solution 1 (Test), Other: Solution 2 (Test), Other: Solution 3 (Test), Other: Solution 4 (Control)Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). |
| Lens B (galyfilcon A) | Other | Other: Solution 1 (Test), Other: Solution 2 (Test), Other: Solution 3 (Test), Other: Solution 4 (Control)Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). |
| Lens C (etafilcon A) | Other | Other: Solution 1 (Test), Other: Solution 2 (Test), Other: Solution 3 (Test), Other: Solution 4 (Control)Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol.
- The subject must be between 18 and 69 years of age.
- The subject must be willing to participate in a 9-month study.
- The subject must require a visual correction in both eyes.
Key exclusion criteria (13 listed)
- Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).
- Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
- Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
- Any active ocular infection.
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 |
|---|---|---|
| Solution 1 (Test)Also: RevitalensEach subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order | Other | Lens A (senofilcon A), Lens B (galyfilcon A), Lens C (etafilcon A) |
| Solution 2 (Test)Also: Pure MoistEach subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order | Other | Lens A (senofilcon A), Lens B (galyfilcon A), Lens C (etafilcon A) |
| Solution 3 (Test)Also: BiotrueEach subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order | Other | Lens A (senofilcon A), Lens B (galyfilcon A), Lens C (etafilcon A) |
| Solution 4 (Control)Also: Clear CareEach subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order | Other | Lens A (senofilcon A), Lens B (galyfilcon A), Lens C (etafilcon A) |
Primary outcome
Overall Comfort Score (Senofilcon A Lens)
Time frame: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Overall Comfort Score (Galyfilcon A Lens)
Time frame: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Overall Comfort Score (Etafilcon A Lens)
Time frame: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27391533Schulze MM, Srinivasan S, Hickson-Curran SB, Berntsen DA, Howarth GF, Toubouti Y, Morgan P, Nichols JJ, Jones LW; Performance of Contact Lens Solutions Study Group. Lid Wiper Epitheliopathy in Soft Contact Lens Wearers. Optom Vis Sci. 2016 Aug;93(8):943-54. doi: 10.1097/OPX.0000000000000919.
- Derived from this study: PubMed 27309523Berntsen DA, Hickson-Curran SB, Jones LW, Mathew JH, Maldonado-Codina C, Morgan PB, Schulze MM, Nichols JJ; Performance of Contact Lens Solutions Study Group. Subjective Comfort and Physiology with Modern Contact Lens Care Products. Optom Vis Sci. 2016 Aug;93(8):809-19. doi: 10.1097/OPX.0000000000000901.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solution 1 (Test), Solution 2 (Test) and Solution 3 (Test) in people with Contact Lens Solutions, run by Johnson & Johnson Vision Care, Inc. at 3 sites in 3 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 10 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada, 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 6 Nov 2017). 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?
Overall Comfort Score (Senofilcon A Lens) (time frame: 2-Week Follow-up). The study lists 3 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 NCT01791517, which also lists 2 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 Jun 2018.