Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.
Interventions
DEVICESpectacles
spectacle wearers
Sponsors
Ohio State University
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate). * Willing to comply with the study visit schedule. * Ages 15 to 39. * Has access to a cellular telephone with text messaging capabilities. * Has a current pair of spectacles. * 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'. * Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC. * Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye. * Subject agrees to intent of wearing the CLs at minimum 6 hours/day for at least 4 days per week. * They agree not to participate in other clinical research during the duration of this study.
Exclusion criteria
* Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear. * Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus). * Systemic disease, which might interfere with contact lens wear. * Medication usage that may be associated with eye dryness. * Use of any topical medication such as eye drops or ointment. * Pregnant or lactating (by self-report). * Aphakia. * Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear. * Have participated in any other clinical trial or research in the two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limbal Hyperemia | 1 Year | Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. |
| Papillary Conjunctivitis | 1 Year | Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. |
| Conjunctival Hyperemia | 1 Year | Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. |
| Corneal Staining | 1 Year | Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. |
| Conjunctival Staining | 1 Year | Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. |
| Corneal Neovascularization | 1 Year | New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score. |
| Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire | 1 Year | The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfortable Wearing Time | 1 Year | Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit. |
Countries
United States
Participant flow
Recruitment details
There were 157 subjects consented to participate in this study. Fifty-nine (59) subjects were determined to be ineligible. This allotted forty-nine (49) subjects randomly to each study arm for a total of 98 subjects enrolled.
Pre-assignment details
Of the 59 identified as ineligible prior to group assignment, the majority were due to having a preexisting astigmatism.
Participants by arm
| Arm | Count |
|---|---|
| Investigational Silicone Hydrogel Contact Lens Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group. | 49 |
| Spectacles Subjects are randomized to this Control Group. | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-Month Visit | Lost to Follow-up | 2 | 0 |
| 1-Year Visit | Lost to Follow-up | 5 | 3 |
| 2-Week Visit | Withdrawal by Subject | 1 | 0 |
| 3-Month Visit | Lost to Follow-up | 2 | 0 |
| 6-Month Visit | Lost to Follow-up | 2 | 2 |
| 6-Month Visit | Withdrawal by Subject | 6 | 7 |
| Baseline and Dispensed | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Spectacles | Investigational Silicone Hydrogel Contact Lens | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 49 Participants | 98 Participants |
| Age, Continuous | 23.31 years STANDARD_DEVIATION 6.08 | 22.57 years STANDARD_DEVIATION 6.67 | 22.94 years STANDARD_DEVIATION 6.36 |
| Region of Enrollment United States | 49 participants | 49 participants | 98 participants |
| Sex: Female, Male Female | 21 Participants | 28 Participants | 49 Participants |
| Sex: Female, Male Male | 28 Participants | 21 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Conjunctival Hyperemia
Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time frame: 1 Year
Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Silicone Hydrogel Contact Lens | Conjunctival Hyperemia | 0.26 units on a scale |
| Spectacles | Conjunctival Hyperemia | 0.28 units on a scale |
Primary
Conjunctival Staining
Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time frame: 1 Year
Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Silicone Hydrogel Contact Lens | Conjunctival Staining | 1.41 units on a scale |
| Spectacles | Conjunctival Staining | 0.39 units on a scale |
Primary
Corneal Neovascularization
New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time frame: 1 Year
Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Silicone Hydrogel Contact Lens | Corneal Neovascularization | 0.30 units on a scale |
| Spectacles | Corneal Neovascularization | 0.09 units on a scale |
Primary
Corneal Staining
Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.
Time frame: 1 Year
Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Silicone Hydrogel Contact Lens | Corneal Staining | 0.26 Efron Scale (0.1 Unit increments) |
| Spectacles | Corneal Staining | 0.12 Efron Scale (0.1 Unit increments) |
Primary
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire
The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.
Time frame: 1 Year
Population: Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Investigational Silicone Hydrogel Contact Lens | Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire | Comparison of 6-Month Visit - Last Visit | 0.62 units on a scale |
| Investigational Silicone Hydrogel Contact Lens | Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire | Comparison of First Visit - Last Visit | -4.97 units on a scale |
Primary
Limbal Hyperemia
Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time frame: 1 Year
Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Silicone Hydrogel Contact Lens | Limbal Hyperemia | 0.56 units on a scale |
| Spectacles | Limbal Hyperemia | 0.30 units on a scale |
Primary
Papillary Conjunctivitis
Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time frame: 1 Year
Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Silicone Hydrogel Contact Lens | Papillary Conjunctivitis | 0.98 units on a scale |
| Spectacles | Papillary Conjunctivitis | 0.47 units on a scale |
Secondary
Comfortable Wearing Time
Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.
Time frame: 1 Year
Population: Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Silicone Hydrogel Contact Lens | Comfortable Wearing Time | 10.25 Hours |