Myopia
Conditions
Brief summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.
Interventions
DEVICEBausch & Lomb Test lens
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
DEVICECiba Vision soft contact lens
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates). * Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. * Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.
Exclusion criteria
* An active ocular disease, any corneal infiltrative response or are using any ocular medications. * Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months. * Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Any scar or neovascularization within the central 4mm of the cornea. * Have had any corneal surgery. * Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Any systemic disease affecting ocular health. * Using any systemic or topical medications that will affect ocular physiology or lens performance. * Currently wear monovision, multifocal, or toric contact lenses. * Allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | One week | The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | One week | The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 5 clinical sites in the US. First participant was enrolled 08/08/2011 and last participant exited on 09/01/2011.
Pre-assignment details
100 participants (200 eyes) were enrolled in this 2 week crossover study. Participants were divided into 2 groups wearing one study lens for 1 week and then crossing over to the other study lens for 1 week. 96 participants completed the study, 1 participant was ineligible at baseline while 3 participants were discontinued during the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All 99 participants in study | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1st Period | Inability to maintain wear | 0 | 1 |
| 1st Period | Ineligible | 0 | 1 |
| 1st Period | Positive slit lamp finding | 0 | 1 |
| 1st Period | Unacceptable lens movement | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Region of Enrollment United States | 99 participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 99 | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 | 0 / 99 |
Outcome results
Primary
Visual Acuity
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
Time frame: One week
Population: All eligible dispensed eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bausch+Lomb Test Lens | Visual Acuity | -0.054 LogMAR | Standard Deviation 0.115 |
| Ciba Vision Soft Contact Lens | Visual Acuity | -0.051 LogMAR | Standard Deviation 0.115 |
Secondary
Overall Comfort
The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.
Time frame: One week
Population: All eligible dispensed eyes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bausch+Lomb Test Lens | Overall Comfort | 81.9 units on a scale | Standard Deviation 21.7 |
| Ciba Vision Soft Contact Lens | Overall Comfort | 82.7 units on a scale | Standard Deviation 21.8 |