Myopia
Conditions
Brief summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.
Interventions
DEVICEInvestigational lens
Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.
DEVICEAir Optix Aqua lens
Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * Be myopic and require lens correction in each eye. * Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion criteria
* Any systemic disease affecting ocular health. * Using any systemic or topical medications that will affect ocular physiology or lens performance. * An active ocular disease, any corneal infiltrative response or are using any ocular medications. * Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | At 1 week follow up | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | At 1 week follow up | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities. |
| Symptoms and Complaints | At 1 week follow up | At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score. |
Countries
United States
Participant flow
Recruitment details
A total of 66 participants (132 eyes) were enrolled in the study. One-half were randomized to receive the investigational lens, and the other half were randomized to receive the control lens. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.
Participants by arm
| Arm | Count |
|---|---|
| Overall All participants received both treatment groups. | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 31.1 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time frame: At 1 week follow up
Population: There were 65 subjects (130 eyes) in each group for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Lens | Visual Acuity | -0.038 logMAR | Standard Deviation 0.088 |
| Air Optix Aqua Lens | Visual Acuity | -0.040 logMAR | Standard Deviation 0.088 |
Secondary
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.
Time frame: At 1 week follow up
Population: There were 65 subjects (130 eyes) in each group for this outcome measure.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Investigational Lens | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 0 eyes |
| Air Optix Aqua Lens | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 0 eyes |
Secondary
Symptoms and Complaints
At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score.
Time frame: At 1 week follow up
Population: There were 65 subjects (130 eyes) in each group for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Lens | Symptoms and Complaints | Redness | 92.1 score on a scale | Standard Deviation 11.3 |
| Investigational Lens | Symptoms and Complaints | Burning/stinging upon insertion | 89.7 score on a scale | Standard Deviation 16.7 |
| Investigational Lens | Symptoms and Complaints | Vision upon insertion | 88.1 score on a scale | Standard Deviation 14.8 |
| Investigational Lens | Symptoms and Complaints | Ease of handling/insertion | 86.3 score on a scale | Standard Deviation 17.8 |
| Investigational Lens | Symptoms and Complaints | Vision | 88.3 score on a scale | Standard Deviation 14.8 |
| Investigational Lens | Symptoms and Complaints | Overall comfort | 85.7 score on a scale | Standard Deviation 18.4 |
| Investigational Lens | Symptoms and Complaints | Vision in low light | 86.9 score on a scale | Standard Deviation 14.9 |
| Investigational Lens | Symptoms and Complaints | Ease of handling/removal | 90.7 score on a scale | Standard Deviation 13 |
| Investigational Lens | Symptoms and Complaints | Lens cleanness upon insertion | 91.6 score on a scale | Standard Deviation 12.2 |
| Investigational Lens | Symptoms and Complaints | Dryness | 83.0 score on a scale | Standard Deviation 19.8 |
| Investigational Lens | Symptoms and Complaints | Lens cleanness upon removal | 87.4 score on a scale | Standard Deviation 17.6 |
| Investigational Lens | Symptoms and Complaints | Comfort upon insertion | 86.6 score on a scale | Standard Deviation 18.9 |
| Investigational Lens | Symptoms and Complaints | Overall impression | 83.9 score on a scale | Standard Deviation 19.4 |
| Investigational Lens | Symptoms and Complaints | Itchiness | 90.2 score on a scale | Standard Deviation 16.2 |
| Investigational Lens | Symptoms and Complaints | Lens cleanness | 87.9 score on a scale | Standard Deviation 17 |
| Investigational Lens | Symptoms and Complaints | Comfort at end of day | 80.1 score on a scale | Standard Deviation 22.7 |
| Air Optix Aqua Lens | Symptoms and Complaints | Lens cleanness | 89.6 score on a scale | Standard Deviation 17 |
| Air Optix Aqua Lens | Symptoms and Complaints | Burning/stinging upon insertion | 90.5 score on a scale | Standard Deviation 16.7 |
| Air Optix Aqua Lens | Symptoms and Complaints | Comfort upon insertion | 86.9 score on a scale | Standard Deviation 18.9 |
| Air Optix Aqua Lens | Symptoms and Complaints | Overall comfort | 87.8 score on a scale | Standard Deviation 18.4 |
| Air Optix Aqua Lens | Symptoms and Complaints | Comfort at end of day | 79.2 score on a scale | Standard Deviation 22.7 |
| Air Optix Aqua Lens | Symptoms and Complaints | Ease of handling/insertion | 91.7 score on a scale | Standard Deviation 17.8 |
| Air Optix Aqua Lens | Symptoms and Complaints | Dryness | 81.8 score on a scale | Standard Deviation 19.8 |
| Air Optix Aqua Lens | Symptoms and Complaints | Itchiness | 90.4 score on a scale | Standard Deviation 16.2 |
| Air Optix Aqua Lens | Symptoms and Complaints | Redness | 93.1 score on a scale | Standard Deviation 11.3 |
| Air Optix Aqua Lens | Symptoms and Complaints | Vision upon insertion | 92.7 score on a scale | Standard Deviation 14.8 |
| Air Optix Aqua Lens | Symptoms and Complaints | Vision | 90.7 score on a scale | Standard Deviation 14.8 |
| Air Optix Aqua Lens | Symptoms and Complaints | Vision in low light | 88.6 score on a scale | Standard Deviation 14.9 |
| Air Optix Aqua Lens | Symptoms and Complaints | Lens cleanness upon insertion | 93.4 score on a scale | Standard Deviation 12.2 |
| Air Optix Aqua Lens | Symptoms and Complaints | Lens cleanness upon removal | 89.5 score on a scale | Standard Deviation 17.6 |
| Air Optix Aqua Lens | Symptoms and Complaints | Overall impression | 84.5 score on a scale | Standard Deviation 19.4 |
| Air Optix Aqua Lens | Symptoms and Complaints | Ease of handling/removal | 93.2 score on a scale | Standard Deviation 13 |