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CompletedNCT02537522Updated Jul 11, 2017Results posted

Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

A Phase 4 interventional study of Contact Lenses with 8.5 BC and Contact Lenses with 9.0 BC in Contact Lens Base Curve (BC) Fit and Comfort, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by Johnson & Johnson Vision Care, Inc. · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.

02

Conditions studied

  • Contact Lens Base Curve (BC) Fit and Comfort
03

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  • The subject must be no less than 18 and no more than 45 years of age with no presbyopic add.
  • The subject must be willing and able to adhere to the instructions set out in the protocol.
  • The subject must be an adapted soft contact lens wearer in both eyes.
  • The subject must be willing to wear the study contact lenses up to 14 hours/day.
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
  • The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
  • The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
  • The subject must require a visual correction in both eyes (no monofit or monovision allowed).
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion criteria

Exclusion Criteria:

  • Current 1-DAY ACUVUE® TruEye® wearers
  • Anisometropia of 1.00 D or greater
  • Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
  • Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
  • Pregnancy or lactation
  • Diabetes
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Test/Control - Phase 1

    Over visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner.

    Device: Contact Lenses with 8.5 BC · Device: Contact Lenses with 9.0 BC

  • Experimental
    Control/Test - Phase 1

    Over visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner.

    Device: Contact Lenses with 8.5 BC · Device: Contact Lenses with 9.0 BC

  • Experimental
    Test/Control - Phase 2

    During Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner.

    Device: Contact Lenses with 8.5 BC · Device: Contact Lenses with 9.0 BC

  • Experimental
    Control/Test - Phase 2

    During Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner.

    Device: Contact Lenses with 8.5 BC · Device: Contact Lenses with 9.0 BC

Interventions

  • DeviceContact Lenses with 8.5 BC

    Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.

    Also known as: Marketed Daily Disposable Soft Contact Lenses

  • DeviceContact Lenses with 9.0 BC

    Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.

    Also known as: Marketed Daily Disposable Soft Contact Lenses

06

What researchers measure

Primary outcomes

  1. Correlation Between Subjective CLUE Comfort and Keratometry

    CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire 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. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter \[DK\]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.

    Time frame: 3-day follow-up

  2. Correlation Between Subjective CLUE Comfort and Corneal Diameter

    Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire 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. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter \[HVID\]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.

    Time frame: 3-day follow-up

07

Results

Posted Jan 10, 2017

Participant flow

Phase I - Contralateral
Participant flow — Phase I - Contralateral
MilestoneTest/Control - Phase 1Control/Test - Phase 1Test/Control - Phase 2Control/Test - Phase 2
Started343700
Completed192700
Not completed151000
Withdrew: Subject no longer eligible15700
Withdrew: Withdrawal by subject0100
Withdrew: Incorrect randomization0100
Withdrew: Unsatisfactory lens fitting0100
Phase II - Period 1 Bilateral
Participant flow — Phase II - Period 1 Bilateral
MilestoneTest/Control - Phase 1Control/Test - Phase 1Test/Control - Phase 2Control/Test - Phase 2
Started002323
Completed002322
Not completed0001
Withdrew: Adverse event0001
Phase II - Period 2 Bilateral
Participant flow — Phase II - Period 2 Bilateral
MilestoneTest/Control - Phase 1Control/Test - Phase 1Test/Control - Phase 2Control/Test - Phase 2
Started002322
Completed002322
Not completed0000

Outcome measures

PrimaryCorrelation Between Subjective CLUE Comfort and Keratometry

CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire 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. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter \[DK\]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.

Time frame:
3-day follow-up
Reported as:
Number · Pearson Correlation
Correlation Between Subjective CLUE Comfort and Keratometry
Pearson CorrelationNarafilcon A- 8.5 Base CurveNarafilcon A- 9.0 Base Curve
Minimum Keratometry measurements0.0420.004
Maximum Keratometry measurements-0.001-0.002
PrimaryCorrelation Between Subjective CLUE Comfort and Corneal Diameter

Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire 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. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter \[HVID\]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.

Time frame:
3-day follow-up
Reported as:
Number · Pearson Correlation
Correlation Between Subjective CLUE Comfort and Corneal Diameter
Pearson CorrelationNarafilcon A- 8.5 Base CurveNarafilcon A- 9.0 Base Curve
Minimum Corneal diameter0.011-0.086
Maximum Corneal diameter0.021-0.119

Adverse events

Collected over Throughout the duration of the study. Approximately 1-week per subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Narafilcon A- 8.5 Base Curve—0/71 (0%)0/71 (0%)
Narafilcon A- 9.0 Base Curve—0/71 (0%)0/71 (0%)

Baseline characteristics

All subjects that were dispensed at least one study lens.

Age, Continuous
Age, Continuous(years)Dispensed Subjects
Mean28.7 ± 6.24
Sex: Female, Male
Sex: Female, Male(Participants)Dispensed Subjects
Female43
Male28
Region of Enrollment
Region of Enrollment(participants)Dispensed Subjects
United States71
08

Study locations

2 sites
  • Jacksonville, Florida 32205, United States
  • Jacksonville, Florida 32256, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02537522
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Sep 1, 2015
Start date
Jul 1, 2015
Primary completion
Jul 1, 2015
Completion
Jul 1, 2015
Results posted
Jan 10, 2017
Last update
Jul 11, 2017

Oversight

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

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