Myopia
Conditions
Keywords
Daily disposable contact lenses, Multi-purpose disinfecting solutions
Brief summary
The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.
Detailed description
Corneal staining and subjective responses for ocular redness and comfort will be compared.
Interventions
DEVICENelfilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
DEVICEEtafilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
DEVICEFID 107027 solution
Commercially marketed solution for contact lens disinfection
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses. * Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* History of hypersensitivity to any components of the multi-purpose solution. * Evidence or history of ocular conditions as prescribed in protocol. * One functional eye or a monofit lens * Any slit-lamp finding score equal to 1 at Visit 1 of each study period. * Significant corneal staining at visit 1 of each study period as prescribed in protocol. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Corneal Staining Area | After 2 hours of wear | Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together. |
| Total Corneal Staining Type | After 2 hours of wear | Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Comfort | After 2 hours of wear | Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes feel... with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable. |
| Ocular Redness | After two hours of wear | Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes look... with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red. |
Countries
United States
Participant flow
Recruitment details
64 subjects currently wearing hydrogel or silicone hydrogel lenses on a daily wear schedule for at least two weeks were enrolled between 1/7/08 and 2/1/08 by 4 US optometry sites
Pre-assignment details
18 hours of no contact lens wear (glasses only) served as the wash out before Period 1. This reporting group includes all enrolled and dispensed participants as treated.
Participants by arm
| Arm | Count |
|---|---|
| Nelfilcon A Contact Lens Commercially marketed, single vision, soft contact lens for daily disposable wear | 29 |
| Etafilcon A Contact Lens Commercially marketed, single vision, soft contact lens for daily disposable wear | 34 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Washout Period, 3 Days (+/-1 Day) | Failed inc criteria Second Intervention | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Nelfilcon A Contact Lens | Etafilcon A Contact Lens | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 34 Participants | 61 Participants |
| Age Continuous | 37.59 years STANDARD_DEVIATION 13.9 | 38.56 years STANDARD_DEVIATION 12.42 | 38.11 years STANDARD_DEVIATION 13.02 |
| Sex: Female, Male Female | 16 Participants | 25 Participants | 41 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 34 | 0 / 34 |
Outcome results
Primary
Average Corneal Staining Area
Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.
Time frame: After 2 hours of wear
Population: This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A / FID 107027 | Average Corneal Staining Area | 0.27 Percentage area of cornea | Standard Deviation 0.39 |
| Nelfilcon A / no Soak | Average Corneal Staining Area | 0.08 Percentage area of cornea | Standard Deviation 0.13 |
| Etafilcon A / FID 107027 | Average Corneal Staining Area | 0.34 Percentage area of cornea | Standard Deviation 0.63 |
| Etafilcon A / no Soak | Average Corneal Staining Area | 0.18 Percentage area of cornea | Standard Deviation 0.25 |
Primary
Total Corneal Staining Type
Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed.
Time frame: After 2 hours of wear
Population: This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A / FID 107027 | Total Corneal Staining Type | 1.59 Units on a scale | Standard Deviation 1.43 |
| Nelfilcon A / no Soak | Total Corneal Staining Type | 0.79 Units on a scale | Standard Deviation 1.18 |
| Etafilcon A / FID 107027 | Total Corneal Staining Type | 1.32 Units on a scale | Standard Deviation 1.8 |
| Etafilcon A / no Soak | Total Corneal Staining Type | 1.00 Units on a scale | Standard Deviation 1.23 |
Secondary
Ocular Comfort
Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes feel... with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable.
Time frame: After 2 hours of wear
Population: This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A / FID 107027 | Ocular Comfort | 1.86 Units on a scale | Standard Deviation 0.92 |
| Nelfilcon A / no Soak | Ocular Comfort | 1.83 Units on a scale | Standard Deviation 0.8 |
| Etafilcon A / FID 107027 | Ocular Comfort | 1.65 Units on a scale | Standard Deviation 0.69 |
| Etafilcon A / no Soak | Ocular Comfort | 1.88 Units on a scale | Standard Deviation 0.88 |
Secondary
Ocular Redness
Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes look... with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red.
Time frame: After two hours of wear
Population: This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A / FID 107027 | Ocular Redness | 2.07 Units on a scale | Standard Deviation 0.46 |
| Nelfilcon A / no Soak | Ocular Redness | 2.10 Units on a scale | Standard Deviation 0.72 |
| Etafilcon A / FID 107027 | Ocular Redness | 2.18 Units on a scale | Standard Deviation 0.76 |
| Etafilcon A / no Soak | Ocular Redness | 2.06 Units on a scale | Standard Deviation 0.69 |