Contact Lens Solutions
Conditions
Brief summary
The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).
Interventions
OTHERSolution 1 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
OTHERSolution 2 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
OTHERSolution 3 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
OTHERSolution 4 (Control)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol. 3. The subject must be between 18 and 69 years of age. 4. The subject must be willing to participate in a 9-month study. 5. The subject must require a visual correction in both eyes. 6. Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye. 7. The subject must have best-corrected visual acuity of 0.20 or better in each eye. 8. The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment. 9. The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane. 10. The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
Exclusion criteria
1. Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued). 2. Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution. 3. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.). 4. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear. 5. Any active ocular infection. 6. Current use of topical ophthalmic medications. 7. History of binocular vision abnormality or strabismus. 8. More than occasional use of dry eye/rewetting drops (more than 2 times per day on average). 9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report. 10. History of severe allergic reaction or anaphylaxis. 11. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear. 12. Employee of the investigational clinic (e.g. investigator, coordinator, technician) 13. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort Score (Senofilcon A Lens) | 2-Week Follow-up | CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. 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). |
| Overall Comfort Score (Galyfilcon A Lens) | 2-Week Follow-up | CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. 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). |
| Overall Comfort Score (Etafilcon A Lens) | 2-Week Follow-up | CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. 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). |
Countries
Canada, United Kingdom, United States
Participant flow
Recruitment details
A total of 269 Subjects were enrolled into this study. Of the enrolled 33 subjects did not meet the eligibility criteria. In Phase I 28 subjects were discontinued and 208 subjects completed Phase I. Of the 208 subjects that continued into Phase II 187 subjects completed the study and 21 subjects were discontinued from the from Phase II.
Pre-assignment details
Subjects were first randomized to 1 of 3 lenses(Lens A: senofilcon A, Lens B: galyfilcon A, Lens C: etafilcon A), then within each lens subjects were randomized to 1 of 12 unique solution sequences, totaling in 36 sequences. Due to such a large number of sequences for reporting purposes, subject disposition is reported by solution and period.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A All subjects that were randomized to the study lens etafilcon A and 1 of 12 possible solution sequences. | 80 |
| Galyfilcon A All subjects that were randomized to the study lens galyfilcon A and 1 of 12 possible solution sequences. | 78 |
| Senofilcon A All subjects that were randomized to the study lens senofilcon A and 1 of 12 possible solution sequences. | 78 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase II | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 0 | 0 |
| Phase II | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase II | Lens Handling Difficulties | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Phase II | Lost to Follow-up | 1 | 0 | 1 | 0 | 1 | 2 | 0 | 1 | 1 | 1 | 0 | 0 |
| Phase II | Pre-Existing Ocular Issue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Phase II | Unsatisfactory Lens Fitting | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Phase II | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 1 | 0 |
| Phase I: Period 1 | Adverse Event | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 1 | Lens Handling DIfficulties | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Phase I: Period 1 | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 |
| Phase I: Period 1 | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 1 | Unsatisfactory Lens Fitting | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 1 | Withdrawal by Subject | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 2 | Lens Discomfort | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 2 | Lost to Follow-up | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 2 | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 2 | Unsatisfactory Lens Fit | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 2 | Unsatisfactory Visual Response | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Phase I: Period 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Phase I: Period 3 | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase I: Period 3 | Lens Discomfort | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Phase I: Period 3 | Lost to Follow-up | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Etafilcon A | Galyfilcon A | Senofilcon A | Total |
|---|---|---|---|---|
| Age, Continuous | 30.33 years STANDARD_DEVIATION 9.726 | 30.38 years STANDARD_DEVIATION 10.091 | 29.78 years STANDARD_DEVIATION 9.938 | 30.17 years STANDARD_DEVIATION 9.879 |
| Race/Ethnicity, Customized Asian | 18 Participants | 18 Participants | 22 Participants | 58 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 5 Participants | 6 Participants | 20 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 10 Participants | 6 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 52 Participants | 45 Participants | 43 Participants | 140 Participants |
| Region of Enrollment Canada | 28 Participants | 26 Participants | 26 Participants | 80 Participants |
| Region of Enrollment United Kingdom | 26 Participants | 28 Participants | 25 Participants | 79 Participants |
| Region of Enrollment United States | 26 Participants | 24 Participants | 27 Participants | 77 Participants |
| Sex: Female, Male Female | 55 Participants | 50 Participants | 53 Participants | 158 Participants |
| Sex: Female, Male Male | 25 Participants | 28 Participants | 25 Participants | 78 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 | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 78 | 0 / 78 | 0 / 80 | 0 / 78 | 0 / 78 | 0 / 80 | 0 / 78 | 0 / 78 | 0 / 80 | 0 / 78 | 0 / 78 | 0 / 80 |
| serious Total, serious adverse events | 1 / 78 | 0 / 78 | 0 / 80 | 0 / 78 | 0 / 78 | 0 / 80 | 1 / 78 | 0 / 78 | 1 / 80 | 1 / 78 | 0 / 78 | 0 / 80 |
Outcome results
Primary
Overall Comfort Score (Etafilcon A Lens)
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. 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).
Time frame: 2-Week Follow-up
Population: The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solution 1(RevitaLens) | Overall Comfort Score (Etafilcon A Lens) | 62.57 units on a scale | Standard Deviation 25.158 |
| Solution 2(PureMoist) | Overall Comfort Score (Etafilcon A Lens) | 67.44 units on a scale | Standard Deviation 19.65 |
| Solution 3(Biotrue) | Overall Comfort Score (Etafilcon A Lens) | 62.43 units on a scale | Standard Deviation 21.492 |
| Solution 4(Clear Care) | Overall Comfort Score (Etafilcon A Lens) | 65.33 units on a scale | Standard Deviation 21.163 |
Primary
Overall Comfort Score (Galyfilcon A Lens)
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. 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).
Time frame: 2-Week Follow-up
Population: The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solution 1(RevitaLens) | Overall Comfort Score (Galyfilcon A Lens) | 59.79 units on a scale | Standard Deviation 23.43 |
| Solution 2(PureMoist) | Overall Comfort Score (Galyfilcon A Lens) | 56.95 units on a scale | Standard Deviation 24.679 |
| Solution 3(Biotrue) | Overall Comfort Score (Galyfilcon A Lens) | 58.52 units on a scale | Standard Deviation 22.197 |
| Solution 4(Clear Care) | Overall Comfort Score (Galyfilcon A Lens) | 59.83 units on a scale | Standard Deviation 22.437 |
Primary
Overall Comfort Score (Senofilcon A Lens)
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. 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).
Time frame: 2-Week Follow-up
Population: The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solution 1(RevitaLens) | Overall Comfort Score (Senofilcon A Lens) | 64.42 units on a scale | Standard Deviation 22.536 |
| Solution 2(PureMoist) | Overall Comfort Score (Senofilcon A Lens) | 59.73 units on a scale | Standard Deviation 25.47 |
| Solution 3(Biotrue) | Overall Comfort Score (Senofilcon A Lens) | 63.75 units on a scale | Standard Deviation 21.796 |
| Solution 4(Clear Care) | Overall Comfort Score (Senofilcon A Lens) | 63.47 units on a scale | Standard Deviation 23.739 |