Visual Disorder
Conditions
Brief 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. 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.
Interventions
DEVICEInvestigational Lens 1
One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
DEVICEInvestigational Lens 2
One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
DEVICEInvestigational Lens 3
One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
DEVICEetafilcon 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.
DEVICEetafilcon A (1-Day)
2-week contact lens adaptation period wearing prior to randomization
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort Score | Time Frame Up to 6 months | 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. |
| Overall Vision Score | Time Frame Up to 6 months | 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. |
Countries
India
Participant flow
Recruitment details
This study utilized an adaptation period of 14 days prior to dispensing the extended wear contact lenses. A total of 171 subjects were enrolled into the adaption period. Of those enrolled into this period 168 were dispensed a study lens and 3 did not meet the eligibility criteria. Of the 168 dispensed subjects 142 completed the adaptation period.
Pre-assignment details
A total of 26 subjects were discontinued from the adaptation period. A total of 142 subjects were enrolled into the extended wear period. Of the enrolled subjects, all 142 were dispensed a study lens. Of the dispensed subjects in the extended wear period 58 completed the study and 84 subjects discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects dispensed at least 1 study lens. | 168 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Adaptation Period | Adverse Event | 0 | 0 | 0 | 0 | 2 |
| Adaptation Period | Lens Handling Difficultes | 0 | 0 | 0 | 0 | 8 |
| Adaptation Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 14 |
| Adaptation Period | Unsatisfactory Lens Fitting | 0 | 0 | 0 | 0 | 2 |
| Extended Wear Period | Adverse Event | 17 | 11 | 16 | 3 | 0 |
| Extended Wear Period | Lost to Follow-up | 0 | 1 | 2 | 1 | 0 |
| Extended Wear Period | Missed too many scheduled visits | 0 | 0 | 1 | 3 | 0 |
| Extended Wear Period | Unsatisfactory Lens Fitting | 1 | 0 | 0 | 0 | 0 |
| Extended Wear Period | Withdrawal by Subject | 10 | 9 | 4 | 5 | 0 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 20.2 Years STANDARD_DEVIATION 2.8 |
| Race/Ethnicity, Customized Asian Indian | 168 Participants |
| Sex/Gender, Customized Female | 108 Participants |
| Sex/Gender, Customized Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 168 | 0 / 36 | 0 / 35 | 0 / 36 | 0 / 35 |
| other Total, other adverse events | 12 / 168 | 36 / 36 | 27 / 35 | 33 / 36 | 22 / 35 |
| serious Total, serious adverse events | 0 / 168 | 0 / 36 | 0 / 35 | 3 / 36 | 1 / 35 |
Outcome results
Primary
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.
Time frame: Up to 6 months
Population: The analysis population consists of all subjects that were enrolled into the extended wear period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Lens 1 | Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) | 14 Number of Events |
| Investigational Lens 3 | Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) | 13 Number of Events |
| Investigational Lens 2 | Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) | 12 Number of Events |
| Etafilcon A (Resuable) | Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) | 1 Number of Events |
Secondary
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.
Time frame: Time Frame Up to 6 months
Population: The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Lens 1 | Overall Comfort Score | 1-Day Follow-up | 59.39 Units on a Scale | Standard Deviation 14.263 |
| Investigational Lens 1 | Overall Comfort Score | 5-Day Follow-up | 58.38 Units on a Scale | Standard Deviation 9.293 |
| Investigational Lens 1 | Overall Comfort Score | 12-Day Follow-up | 60.94 Units on a Scale | Standard Deviation 9.62 |
| Investigational Lens 1 | Overall Comfort Score | 26-Day Follow-up | 60.20 Units on a Scale | Standard Deviation 12.851 |
| Investigational Lens 1 | Overall Comfort Score | 88-Day Follow-up | 59.54 Units on a Scale | Standard Deviation 7.474 |
| Investigational Lens 1 | Overall Comfort Score | 180-Day Follow-up | 57.81 Units on a Scale | Standard Deviation 9.133 |
| Investigational Lens 3 | Overall Comfort Score | 180-Day Follow-up | 62.69 Units on a Scale | Standard Deviation 14.6 |
| Investigational Lens 3 | Overall Comfort Score | 26-Day Follow-up | 65.41 Units on a Scale | Standard Deviation 16.467 |
| Investigational Lens 3 | Overall Comfort Score | 1-Day Follow-up | 60.22 Units on a Scale | Standard Deviation 9.005 |
| Investigational Lens 3 | Overall Comfort Score | 12-Day Follow-up | 65.74 Units on a Scale | Standard Deviation 12.091 |
| Investigational Lens 3 | Overall Comfort Score | 5-Day Follow-up | 60.12 Units on a Scale | Standard Deviation 8.447 |
| Investigational Lens 3 | Overall Comfort Score | 88-Day Follow-up | 55.59 Units on a Scale | Standard Deviation 15.247 |
| Investigational Lens 2 | Overall Comfort Score | 5-Day Follow-up | 58.29 Units on a Scale | Standard Deviation 9.735 |
| Investigational Lens 2 | Overall Comfort Score | 12-Day Follow-up | 58.95 Units on a Scale | Standard Deviation 13.457 |
| Investigational Lens 2 | Overall Comfort Score | 26-Day Follow-up | 57.35 Units on a Scale | Standard Deviation 15.28 |
| Investigational Lens 2 | Overall Comfort Score | 180-Day Follow-up | 54.91 Units on a Scale | Standard Deviation 7.578 |
| Investigational Lens 2 | Overall Comfort Score | 88-Day Follow-up | 57.71 Units on a Scale | Standard Deviation 12.15 |
| Investigational Lens 2 | Overall Comfort Score | 1-Day Follow-up | 58.85 Units on a Scale | Standard Deviation 13.102 |
| Etafilcon A (Resuable) | Overall Comfort Score | 88-Day Follow-up | 65.00 Units on a Scale | Standard Deviation 15.657 |
| Etafilcon A (Resuable) | Overall Comfort Score | 180-Day Follow-up | 64.49 Units on a Scale | Standard Deviation 16.12 |
| Etafilcon A (Resuable) | Overall Comfort Score | 5-Day Follow-up | 64.59 Units on a Scale | Standard Deviation 13.301 |
| Etafilcon A (Resuable) | Overall Comfort Score | 26-Day Follow-up | 65.57 Units on a Scale | Standard Deviation 14.513 |
| Etafilcon A (Resuable) | Overall Comfort Score | 1-Day Follow-up | 62.51 Units on a Scale | Standard Deviation 13.431 |
| Etafilcon A (Resuable) | Overall Comfort Score | 12-Day Follow-up | 64.87 Units on a Scale | Standard Deviation 13.831 |
Secondary
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.
Time frame: Time Frame Up to 6 months
Population: The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Lens 1 | Overall Vision Score | 1-Day Follow-up | 55.27 Units on a Scale | Standard Deviation 15.819 |
| Investigational Lens 1 | Overall Vision Score | 5-Day Follow-up | 53.02 Units on a Scale | Standard Deviation 9.117 |
| Investigational Lens 1 | Overall Vision Score | 12-Day Follow-up | 52.17 Units on a Scale | Standard Deviation 13.614 |
| Investigational Lens 1 | Overall Vision Score | 26-Day Follow-up | 52.85 Units on a Scale | Standard Deviation 5.218 |
| Investigational Lens 1 | Overall Vision Score | 88-Day Follow-up | 50.23 Units on a Scale | Standard Deviation 17.08 |
| Investigational Lens 1 | Overall Vision Score | 180-Day Follow-up | 53.49 Units on a Scale | Standard Deviation 9.883 |
| Investigational Lens 3 | Overall Vision Score | 180-Day Follow-up | 54.07 Units on a Scale | Standard Deviation 10.654 |
| Investigational Lens 3 | Overall Vision Score | 26-Day Follow-up | 57.84 Units on a Scale | Standard Deviation 13.257 |
| Investigational Lens 3 | Overall Vision Score | 1-Day Follow-up | 56.78 Units on a Scale | Standard Deviation 14.299 |
| Investigational Lens 3 | Overall Vision Score | 12-Day Follow-up | 59.63 Units on a Scale | Standard Deviation 17.147 |
| Investigational Lens 3 | Overall Vision Score | 5-Day Follow-up | 54.66 Units on a Scale | Standard Deviation 14.398 |
| Investigational Lens 3 | Overall Vision Score | 88-Day Follow-up | 54.22 Units on a Scale | Standard Deviation 14.718 |
| Investigational Lens 2 | Overall Vision Score | 5-Day Follow-up | 52.11 Units on a Scale | Standard Deviation 13.284 |
| Investigational Lens 2 | Overall Vision Score | 12-Day Follow-up | 50.73 Units on a Scale | Standard Deviation 11.715 |
| Investigational Lens 2 | Overall Vision Score | 26-Day Follow-up | 50.38 Units on a Scale | Standard Deviation 17.434 |
| Investigational Lens 2 | Overall Vision Score | 180-Day Follow-up | 50.92 Units on a Scale | Standard Deviation 9.699 |
| Investigational Lens 2 | Overall Vision Score | 88-Day Follow-up | 50.67 Units on a Scale | Standard Deviation 10.777 |
| Investigational Lens 2 | Overall Vision Score | 1-Day Follow-up | 52.87 Units on a Scale | Standard Deviation 12.857 |
| Etafilcon A (Resuable) | Overall Vision Score | 88-Day Follow-up | 63.83 Units on a Scale | Standard Deviation 17.096 |
| Etafilcon A (Resuable) | Overall Vision Score | 180-Day Follow-up | 61.68 Units on a Scale | Standard Deviation 16.426 |
| Etafilcon A (Resuable) | Overall Vision Score | 5-Day Follow-up | 59.55 Units on a Scale | Standard Deviation 15.169 |
| Etafilcon A (Resuable) | Overall Vision Score | 26-Day Follow-up | 59.76 Units on a Scale | Standard Deviation 14.244 |
| Etafilcon A (Resuable) | Overall Vision Score | 1-Day Follow-up | 60.28 Units on a Scale | Standard Deviation 14.723 |
| Etafilcon A (Resuable) | Overall Vision Score | 12-Day Follow-up | 59.59 Units on a Scale | Standard Deviation 14.892 |