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CompletedNCT03475875Updated Jun 4, 2019Results posted

Contact Lenses With New UV-blocker Manufactured With Different Techniques

A Phase 2/3 interventional study of senofilcon A TEST Lens and senofilcon A CONTROL Lens in Correction of Refraction Error and Attenuation of Bright Light, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-04.

Sponsored by Johnson & Johnson Vision Care, Inc. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with one of the study lenses being worn twice. Each study lens is expected to be worn at least five (5) days per week for at least six (6) hours per day worn. There will be no washout period between study lenses.

02

Conditions studied

  • Correction of Refraction Error
  • Attenuation of Bright Light

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
    2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    3. Healthy adult males or females age ≥18 years of age with signed informed consent.
    4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
    5. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
    6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
    7. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 (inclusive) in each eye.
    8. The subject's refractive cylinder must be ≤ -1.00 D in each eye.
    9. Have spherocylindrical best corrected visual acuity of 20/25+3 or better in each eye.

Exclusion criteria

Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Currently pregnant or lactating.
    2. Any active or ongoing 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 bodily diseases or infections, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
    3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. Habitual medications taken by successful contact lens wearers are generally considered acceptable.
    4. Habitual toric, extended wear, or multifocal contact lens wear.
    5. Any current use of ocular medication.
    6. Any known hypersensitivity or allergic reaction to Optifree PureMoist.
    7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
    8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
    9. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    10. Any active or ongoing 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.
    11. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit-lamp scale.
    12. Binocular vision abnormality or strabismus.
    13. 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.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    TEST/CONTROL/CONTROL

    Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject.

    Device: senofilcon A TEST Lens · Device: senofilcon A CONTROL Lens

  • Experimental
    CONTROL/TEST/TEST

    Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject.

    Device: senofilcon A TEST Lens · Device: senofilcon A CONTROL Lens

Interventions

  • Devicesenofilcon A TEST Lens

    senofilcon A with new UV blocker investigational process

  • Devicesenofilcon A CONTROL Lens

    senofilcon A with new UV blocker standard process

05

What researchers measure

Primary outcomes

  1. Overall Comfort Score

    Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.

    Time frame: 2- Week Follow-up Evaluation

  2. Overall Vision Score

    Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.

    Time frame: 2- Week Follow-up Evaluation

06

Results

Posted Jun 4, 2019

Participant flow

A total of 92 subjects were enrolled into this study. Of those enrolled, 91 were dispensed a study lens and 1 subject failed to meet the eligibility criteria. Of the dispensed subjects 83 completed the study while 8 subjects were discontinued.

Period 1
Participant flow — Period 1
MilestoneTest/Control/ControlControl/Test/Test
Started4645
Completed4344
Not completed31
Withdrew: Lost to follow-up10
Withdrew: Adverse event21
Period 2
Participant flow — Period 2
MilestoneTest/Control/ControlControl/Test/Test
Started4344
Completed4043
Not completed31
Withdrew: Adverse event30
Withdrew: Protocol violation01
Period 3
Participant flow — Period 3
MilestoneTest/Control/ControlControl/Test/Test
Started4043
Completed4043
Not completed00

Outcome measures

PrimaryOverall Comfort Score

Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.

Time frame:
2- Week Follow-up Evaluation
Reported as:
Mean · Units on a scale
Overall Comfort Score
Units on a scaleTestControl
Overall Comfort Score61.49 ± 21.08767.27 ± 22.865
Statistical analysis
  • Test vs Control · Linear Mixed Model · Mean difference (final values): -4.3 · 95% CI -7.7 to -0.9Mean difference was calculated as Test - Control
PrimaryOverall Vision Score

Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.

Time frame:
2- Week Follow-up Evaluation
Reported as:
Mean · Units on a scale
Overall Vision Score
Units on a scaleTestControl
Overall Vision Score61.79 ± 17.75864.92 ± 17.444
Statistical analysis
  • Test vs Control · Linear Mixed Model · Mean difference (final values): -1.9 · 95% CI -4.7 to 1.0Mean difference was calculated as Test - Control

Adverse events

Collected over Throughout the entire duration of the study. Approximately 6 weeks per subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test0/91 (0%)0/91 (0%)0/91 (0%)
Control0/91 (0%)0/91 (0%)0/91 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Dispensed Subjects
Mean31.8 ± 6.32
Sex: Female, Male
Sex: Female, Male(Participants)Dispensed Subjects
Female61
Male30
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Dispensed Subjects
American Indian or Native Alaska0
Asian11
Black or African American3
Native Hawaiian or Other Pacific Islander1
White69
Other7
Region of Enrollment
Region of Enrollment(Participants)Dispensed Subjects
United States91
07

Study locations

5 sites
  • VRC-West
    Foster City, California 94404, United States
  • Bartram Eye Clinic
    Jacksonville, Florida 32258, United States
  • Pickens Family Eye Care
    Pickens, South Carolina 29671, United States
  • Optometry Group, LLC
    Memphis, Tennessee 38111, United States
  • William J. Bogus, OD, FAAO
    Salt Lake City, Utah 84106, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 7, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03475875
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Feb 19, 2018
Primary completion
Apr 18, 2018
Completion
Apr 18, 2018
Results posted
Jun 4, 2019
Last update
Jun 4, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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