Myopia
Conditions
Brief summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.
Interventions
DEVICEInvestigational Lens
Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.
DEVICEAcuvue Oasys Lens
Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.
DEVICEAir Optix Aqua Lens
Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must have clear central corneas and be free of any anterior segment disorders. * Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * Subjects must be myopic and require lens correction
Exclusion criteria
* Subjects with any systemic disease affecting ocular health. * Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Subjects with an active ocular disease or are using any ocular medication. * Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (Investigational vs Air Optix Aqua Lens) | 1 week | The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens. |
| Visual Acuity (Investigational vs Acuvue Oasys Lens) | 1 week | The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) | 1 week | The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score. |
| Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) | 1 week | The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score. |
Countries
United States
Participant flow
Recruitment details
This was a randomized, bilateral, three-way crossover, subject-masked study conducted at six sites in the United States. The first participant was enrolled 11/8/2010 and last participant exited on 12/23/2010.
Pre-assignment details
144 participants were equally randomized to one of six treatment sequences. 142 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week. | 144 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Positive Slit lamp finding | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment United States | 144 participants |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 144 |
| serious Total, serious adverse events | 0 / 144 |
Outcome results
Primary
Visual Acuity (Investigational vs Acuvue Oasys Lens)
The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.
Time frame: 1 week
Population: All eligible, dispensed eyes
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Lens | Visual Acuity (Investigational vs Acuvue Oasys Lens) | Baseline | -0.050 LogMAR | Standard Deviation 0.113 |
| Investigational Lens | Visual Acuity (Investigational vs Acuvue Oasys Lens) | 1-week follow-up | -0.034 LogMAR | Standard Deviation 0.109 |
| Air Optix Aqua Lens | Visual Acuity (Investigational vs Acuvue Oasys Lens) | Baseline | -0.048 LogMAR | Standard Deviation 0.113 |
| Air Optix Aqua Lens | Visual Acuity (Investigational vs Acuvue Oasys Lens) | 1-week follow-up | -0.033 LogMAR | Standard Deviation 0.109 |
Primary
Visual Acuity (Investigational vs Air Optix Aqua Lens)
The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.
Time frame: 1 week
Population: All eligible, dispensed eyes
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Lens | Visual Acuity (Investigational vs Air Optix Aqua Lens) | Baseline | -0.050 LogMAR | Standard Deviation 0.116 |
| Investigational Lens | Visual Acuity (Investigational vs Air Optix Aqua Lens) | 1 Week follow-up | -0.034 LogMAR | Standard Deviation 0.111 |
| Air Optix Aqua Lens | Visual Acuity (Investigational vs Air Optix Aqua Lens) | Baseline | -0.060 LogMAR | Standard Deviation 0.116 |
| Air Optix Aqua Lens | Visual Acuity (Investigational vs Air Optix Aqua Lens) | 1 Week follow-up | -0.039 LogMAR | Standard Deviation 0.111 |
Secondary
Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)
The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
Time frame: 1 week
Population: 1-Week Follow-up, All Eligible, Dispensed Eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Lens | Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) | 80.9 units on a scale | Standard Deviation 21.4 |
| Air Optix Aqua Lens | Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) | 86.5 units on a scale | Standard Deviation 21.4 |
Secondary
Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)
The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
Time frame: 1 week
Population: All eligible, dispensed eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Lens | Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) | 80.9 units on a scale | Standard Deviation 21.4 |
| Air Optix Aqua Lens | Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) | 82.1 units on a scale | Standard Deviation 21.4 |