Myopia
Conditions
Keywords
Contact lens
Brief summary
The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.
Interventions
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
DEVICEAir Optix Aqua
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
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
No
Inclusion criteria
* Participants must have clear central corneas and be free of any anterior segment disorders. * Participants 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. * Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.
Exclusion criteria
* Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months. * Participants with any systemic disease affecting ocular health. * Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Participants with an active ocular disease or are using any ocular medication. * Participants who have had any corneal surgery (eg, refractive surgery). * Participants who are allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens | 7 days | Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable. |
| Comfort Throughout the Day - Test Lens vs. Acuvue Oasys | 7 days | Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Wettability, Test Lens vs. Acuvue Oasys | 7 days | Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas \> 0.5 mm in size). |
| Lens Wettability, Test Lens vs. Air Optix Aqua | 7 days | Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas \> 0.5 mm in size). |
Countries
United States
Participant flow
Recruitment details
There were 120 participants enrolled in this bilateral eye, three-period crossover study at four investigative sites in the United States (US). All participants were adapted wearers of soft contact lenses. The first participant was enrolled in the study on 5/10/2010 and the last participant exited the study on 6/10/2010.
Pre-assignment details
Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Of the 120 participants enrolled 2 were ineligible at baseline and 2 discontinued following dispensing of lenses. 116 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Over All Study Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test. | 117 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Period 1 - Baseline | Pregnancy | 1 |
| Period 3- Crossover | + Slit lamp finding | 1 |
Baseline characteristics
| Characteristic | Over All Study |
|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 117 participants |
| Sex: Female, Male Female | 86 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 117 | 0 / 117 | 0 / 117 |
| serious Total, serious adverse events | 0 / 117 | 0 / 117 | 0 / 117 |
Outcome results
Primary
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Time frame: 7 days
Population: All eligible, dispensed eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Contact Lens | Comfort Throughout the Day - Test Lens vs. Acuvue Oasys | 74.3 units on a scale | Standard Deviation 22.1 |
| Acuvue Oasys Contact Lens | Comfort Throughout the Day - Test Lens vs. Acuvue Oasys | 88.0 units on a scale | Standard Deviation 22.1 |
Primary
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Time frame: 7 days
Population: All eligible dispensed eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Contact Lens | Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens | 74.3 units on a scale | Standard Deviation 22.1 |
| Acuvue Oasys Contact Lens | Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens | 79.4 units on a scale | Standard Deviation 22.1 |
Secondary
Lens Wettability, Test Lens vs. Acuvue Oasys
Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas \> 0.5 mm in size).
Time frame: 7 days
Population: All eligible, dispensed eyes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Slight | 14 eyes |
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Moderate | 3 eyes |
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Mild | 1 eyes |
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Severe | 1 eyes |
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Optimal | 210 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Severe | 0 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Optimal | 214 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Slight | 16 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Mild | 0 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Acuvue Oasys | Moderate | 2 eyes |
Secondary
Lens Wettability, Test Lens vs. Air Optix Aqua
Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas \> 0.5 mm in size).
Time frame: 7 days
Population: All eligible, dispensed eyes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Slight | 14 eyes |
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Moderate | 3 eyes |
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Mild | 1 eyes |
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Severe | 1 eyes |
| Investigational Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Optimal | 210 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Severe | 0 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Optimal | 219 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Slight | 10 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Mild | 0 eyes |
| Acuvue Oasys Contact Lens | Lens Wettability, Test Lens vs. Air Optix Aqua | Moderate | 2 eyes |