Visual DisorderNCT02543528
A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week
A study testing Investigational Lens 1, Investigational Lens 2 and Investigational Lens 3 in people with Visual Disorder, run by Johnson & Johnson Vision Care, Inc. at 1 site in India.
Trial summary
This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Disorder
- What is being tested?
- Investigational Lens 1, Investigational Lens 2 and Investigational Lens 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2015to 8 Nov 2016
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must read and understand English 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 instructions set forth in this clinical protocol.
- The subject must be at least 18 and no more than 39 years of age.
- The subject's spherical equivalent distance refraction must be in the range of -1.00 to -5.50 diopters in each eye.
- The subject's refractive cylinder must be less than 1.00 diopters in each eye.
- The subject must have best corrected visual acuity of 20/30 or better in each eye.
- The subject must be without history of contact lens use in the past 12 months.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Who cannot join
- Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month)
- Currently pregnant or lactating (self reported) (subjects who become pregnant during the study will be discontinued).
- Currently a regular smoker (1 or more times per month).
- Current routine swimmer (1 or more times per month).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease (ex. Sjögren's Syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), which may interfere with contact lens wear.
Show all 15Show fewer
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- Any previous or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.).
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self report).
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echo Ionic Silicone Hydrogel 6-Month Extended Wear Investigation
This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of ~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.
- Conditions
- Visual Disorder
- Being tested
- Investigational Lens 1, Investigational Lens 2, Investigational Lens 3, etafilcon A (Reusable), etafilcon A (1-Day)
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Lens 1Device
One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
Investigational Lens 2Device
One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
Investigational Lens 3Device
One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
etafilcon A (Reusable)Device
One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.
etafilcon A (1-Day)Device
2-week contact lens adaptation period wearing prior to randomization
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A (1-Day) and etafilcon A (Reusable) | Experimental | Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. Receives: Device: etafilcon A (Reusable); Device: etafilcon A (1-Day) |
| etafilcon A (1-Day) and Investigational Lens 1 | Experimental | Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. Receives: Device: Investigational Lens 1; Device: etafilcon A (1-Day) |
| etafilcon A (1-Day) and Investigational Lens 2 | Experimental | Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. Receives: Device: Investigational Lens 2; Device: etafilcon A (1-Day) |
| etafilcon A (1-Day) and Investigational Lens 3 | Experimental | Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. Receives: Device: Investigational Lens 3; Device: etafilcon A (1-Day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)
The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.
Measured: Up to 6 months
Secondary outcomes (2)
Overall Comfort Score
Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. 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). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.
Measured: Time Frame Up to 6 months
Overall Vision Score
Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. 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). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.
Measured: Time Frame Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start1 Jun 2015
- Primary completion8 Nov 2016
- Study completion8 Nov 2016
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 Visual DisorderStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 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
- NCT02543528
- Sponsor's protocol ID
- CR-5201
- Status last verified
- Sep 2019
- First submitted
- 6 Aug 2015
- Last updated
- 1 Oct 2019
- 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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echo Ionic Silicone Hydrogel 6-Month Extended Wear Investigation
- ClinicalTrials.gov ID
- NCT02543528
- Acronym / sponsor ID
- CR-5201
- Conditions
- Visual Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 8 Nov 2016 (actual)
- Study completion
- 8 Nov 2016 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 29 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of ~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| etafilcon A (1-Day) and etafilcon A (Reusable) | Experimental | Device: etafilcon A (Reusable), Device: etafilcon A (1-Day)Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
| etafilcon A (1-Day) and Investigational Lens 1 | Experimental | Device: Investigational Lens 1, Device: etafilcon A (1-Day)Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
| etafilcon A (1-Day) and Investigational Lens 2 | Experimental | Device: Investigational Lens 2, Device: etafilcon A (1-Day)Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
| etafilcon A (1-Day) and Investigational Lens 3 | Experimental | Device: Investigational Lens 3, Device: etafilcon A (1-Day)Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The subject must read and understand English 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 instructions set forth in this clinical protocol.
- The subject must be at least 18 and no more than 39 years of age.
- The subject's spherical equivalent distance refraction must be in the range of -1.00 to -5.50 diopters in each eye.
- The subject's refractive cylinder must be less than 1.00 diopters in each eye.
Key exclusion criteria (15 listed)
- Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month)
- Currently pregnant or lactating (self reported) (subjects who become pregnant during the study will be discontinued).
- Currently a regular smoker (1 or more times per month).
- Current routine swimmer (1 or more times per month).
- Any ocular or systemic allergies or diseases that may interfere with 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 |
|---|---|---|
| Investigational Lens 1One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. | Device | etafilcon A (1-Day) and Investigational Lens 1 |
| Investigational Lens 2One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. | Device | etafilcon A (1-Day) and Investigational Lens 2 |
| Investigational Lens 3One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. | Device | etafilcon A (1-Day) and Investigational Lens 3 |
| etafilcon A (Reusable)One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear. | Device | etafilcon A (1-Day) and etafilcon A (Reusable) |
| etafilcon A (1-Day)2-week contact lens adaptation period wearing prior to randomization | Device | etafilcon A (1-Day) and Investigational Lens 1, etafilcon A (1-Day) and Investigational Lens 2, etafilcon A (1-Day) and Investigational Lens 3, etafilcon A (1-Day) and etafilcon A (Reusable) |
Primary outcome
Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)
Time frame: Up to 6 months
The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.
2 secondary outcomes
Overall Comfort Score
Time frame: Time Frame Up to 6 months
Overall Vision Score
Time frame: Time Frame Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Lens 1, Investigational Lens 2 and Investigational Lens 3 in people with Visual Disorder, run by Johnson & Johnson Vision Care, Inc. at 1 site in India.
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 8 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 1 Oct 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 India. 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 29 Mar 2018). 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?
Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) (time frame: Up to 6 months). 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 1 Oct 2019.