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Visual AcuityPhase 2NCT03388138

Clinical Evaluation of Etafilcon A With Ketotifen

A Phase 2 study testing etafilcon A with ketotifen and 1-Day ACUVUE in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
etafilcon A with ketotifen and 1-Day ACUVUE
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
143 participants
Where
6 sitesUnited States
Study dates
6 Dec 2017to 9 Feb 2018
Phase
Phase 2
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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study
  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  • Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Between 18 and 39 (inclusive) years of age at the time of baseline visit.
  • The subject must be a habitual lens wearer for a least 6 days/week and for a minimum of 8 hours per day over the last month.
  • The subject's contact lens correction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
  • The subject's refractive cylinder must be 1.00 D or less in each eye.
  • Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye (Snellen Visual Acuity).

Who cannot join

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Currently pregnant or lactating.
  • Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
  • Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
  • Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear, history of strabismus, or current monovision, multi-focal, or toric contact lens correction.
Show all 13Show fewer
  • Any current use of rewetting drops or ocular medication.
  • Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Biomicroscopy 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 would contraindicate contact lens wear.
  • Any known hypersensitivity or allergic reaction to ketotifen.
  • Participation in any eye drop, contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  • Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Vue Optical Boutique

    Jacksonville, Florida, 32205

  • Maitland Vision Center

    Maitland, Florida, 32751

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • Botetourt Eyecare, LLC

    Salem, Virginia, 24153

  • St. Lucy's Vision Center

    Tampa, Florida, 33625

  • Sacco Eye Group

    Vestal, New York, 13850

Other trials in United States

About this study

This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.

Conditions
Visual Acuity
Being tested
etafilcon A with ketotifen, 1-Day ACUVUE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • etafilcon A with ketotifenCombination product

    Etafilcon A with ketotifen

  • 1-Day ACUVUEDevice

    1-Day ACUVUE

Study groups in NCT03388138
Study groupRoleWhat they receive
K-LensActive comparatoretafilcon A with ketotifen. Subjects between the ages of 18-40 will be randomized into the K-Lens arm and will be scheduled for a total of two study visits with approximately 6-9 days in between.
Receives: Combination Product: etafilcon A with ketotifen
Placebo Contact LensPlacebo comparator1-Day Acuvue. Subjects between the ages of 18-40 will be randomized into the Placebo arm and will be scheduled for a total of two study visits with approximately 6-9 days in between.
Receives: Device: 1-Day ACUVUE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population)

    Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.

    Measured: Baseline (Visit 1) and 1-week follow up (Visit 2)

  2. Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population)

    Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.

    Measured: Baseline (Visit 1) and 1-week follow up (Visit 2)

Secondary outcomes (2)

  1. The Number of Eyes With Clinically Significant Slit Lamp Findings

    Slit lamp findings were assessed using a biomicroscope for each subject eye at all scheduled and unscheduled visits. Clinical significant slit lamp findings are defined as Grade 3 or Grade 4. (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate and Grade 4= Severe). The data was dichotomized as 1=Grade 3 or Grade 4 and 0, otherwise. The number of eyes with clinically significant slit lamp findings for each lens type was reported.

    Measured: Up to 1-Week Follow-up

  2. The Number of Eyes With Unacceptable Lens Fitting

    Lens fit was assessed for each subject and eye using a biomicroscope. Unacceptable lens fit was assessed at all scheduled and unscheduled visits. A subject was deemed to have an unacceptable lens fitting if they met any of the following criteria: (1) Limbal exposure at primary gaze with extreme eye movement, (2) edge lift, (3) excessive movement in primary up gaze, (4) insufficient movement in all three of the following conditions: primary gaze, up gaze and push up test. The number of eyes with unacceptable lens fitting was reported for each lens type.

    Measured: Up to 1-Week Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2018
  2. Study start6 Dec 2017
  3. Primary completion9 Feb 2018
  4. Study completion9 Feb 2018

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03388138
Sponsor's protocol ID
CR-5930
Status last verified
Mar 2022
First submitted
22 Dec 2017
Last updated
17 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing etafilcon A with ketotifen and 1-Day ACUVUE in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 sites 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 8 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 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?

Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) (time frame: Baseline (Visit 1) and 1-week follow up (Visit 2)). 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?

On the ClinicalTrials.gov record for NCT03388138.

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 17 Mar 2022.

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