Contact Lens Base Curve (BC) Fit and Comfort
Conditions
Brief summary
The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.
Interventions
DEVICEContact Lenses with 8.5 BC
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
DEVICEContact Lenses with 9.0 BC
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Subjective CLUE Comfort and Keratometry | 3-day follow-up | 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. |
| Correlation Between Subjective CLUE Comfort and Corneal Diameter | 3-day follow-up | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 72 subjects were enrolled into this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 71 were dispensed lenses. Of the dispensed subjects 45 completed both Phase I and II while 26 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed at least one study lens throughout the course of the study. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Phase I - Contralateral | incorrect randomization | 0 | 1 | 0 | 0 |
| Phase I - Contralateral | Subject no longer eligible | 15 | 7 | 0 | 0 |
| Phase I - Contralateral | unsatisfactory lens fitting | 0 | 1 | 0 | 0 |
| Phase I - Contralateral | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| Phase II - Period 1 Bilateral | Adverse Event | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 28.7 years STANDARD_DEVIATION 6.24 |
| Region of Enrollment United States | 71 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 71 | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 |
Outcome results
Primary
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
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Narafilcon A- 8.5 Base Curve | Correlation Between Subjective CLUE Comfort and Corneal Diameter | Minimum Corneal diameter | 0.011 Pearson Correlation |
| Narafilcon A- 8.5 Base Curve | Correlation Between Subjective CLUE Comfort and Corneal Diameter | Maximum Corneal diameter | 0.021 Pearson Correlation |
| Narafilcon A- 9.0 Base Curve | Correlation Between Subjective CLUE Comfort and Corneal Diameter | Minimum Corneal diameter | -0.086 Pearson Correlation |
| Narafilcon A- 9.0 Base Curve | Correlation Between Subjective CLUE Comfort and Corneal Diameter | Maximum Corneal diameter | -0.119 Pearson Correlation |
Primary
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
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Narafilcon A- 8.5 Base Curve | Correlation Between Subjective CLUE Comfort and Keratometry | Minimum Keratometry measurements | 0.042 Pearson Correlation |
| Narafilcon A- 8.5 Base Curve | Correlation Between Subjective CLUE Comfort and Keratometry | Maximum Keratometry measurements | -0.001 Pearson Correlation |
| Narafilcon A- 9.0 Base Curve | Correlation Between Subjective CLUE Comfort and Keratometry | Minimum Keratometry measurements | 0.004 Pearson Correlation |
| Narafilcon A- 9.0 Base Curve | Correlation Between Subjective CLUE Comfort and Keratometry | Maximum Keratometry measurements | -0.002 Pearson Correlation |