Presbyopia
Conditions
Brief summary
This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add soft contact lenses when used among currently adapted soft contact lens wearers.
Interventions
DEVICELD127025 MF
At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens.
DEVICEAir Optix Aqua MF
At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have physiologically normal anterior segments not exhibiting biomicroscopy findings Grade 2 or greater 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 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye. * Require contact lens correction from -5.00 D to +3.00 D in each eye. * Be Presbyopic and require near add correction from +1.00 D to +1.75 D in each eye. * Be an adapted monovision soft contact lens wearer or multifocal soft contact lens wearer or an adapted spherical soft contact lens wearer who also uses spectacles for near vision correction. * Be willing to use a lens care system as required by the lens replacement schedule. * Has a distance spherical equivalent refraction between -5.50 D and +3.00 D.
Exclusion criteria
* Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses. * Participated in any drug or device clinical investigation (within 14 days) prior to entry into this study and/or during the period of study participation. * Women of childbearing potential if one of the following: pregnant, plans to become pregnant during study, is breast-feeding. * Any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible. * Any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study. * Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Anisometropia (spherical equivalent) of greater than 2.00 D. * Aphakic. * Amblyopic. * Allergic to any component in the study care products. * Meet any of the following criteria: * Ophthalmologist, OD, Optician, Ophthalmologist's Assistant/Technician * employee of a market research firm * employee of manufacturer of contact lens or contact lens care products * Ocular astigmatism of greater than 1.00 D in either eye. * Have had any corneal surgery (ie, refractive surgery). * Toric contact lens wearer. * Have worn gas permeable (GP) contact lenses within the last 30 days or PMMA lenses within the last 3 months. * Have an active ocular disease or are using any ocular medication. * Have any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health during the course of the study. * Using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 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 |
|---|---|---|
| Symptoms/Complaints | At 1 Week follow up | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. |
Countries
United States
Participant flow
Recruitment details
There were 146 participants (292 eyes) were enrolled in this study. One-half of the participants were randomized to receive the investigational lens, and the other half to the control lens. After one week, the participant crossed over to the second lens type for one week.
Participants by arm
| Arm | Count |
|---|---|
| Overall Enrolled Overall participants enrolled. | 145 |
| Total | 145 |
Baseline characteristics
| Characteristic | Overall Enrolled |
|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 5.3 |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 145 | 0 / 145 |
| serious Total, serious adverse events | 0 / 145 | 0 / 145 |
Outcome results
Primary
Mean 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: Eligible, dispensed eyes assessed for visual acuity are included in the analysis population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LD127025 MF | Mean Visual Acuity | -0.026 logMAR | Standard Deviation 0.07 |
| Air Optix Aqua MF | Mean Visual Acuity | 0.008 logMAR | Standard Deviation 0.078 |
Secondary
Symptoms/Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Time frame: At 1 Week follow up
Population: Eligible, dispensed eyes assessed for symptoms/complaints are included in the analysis population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LD127025 MF | Symptoms/Complaints | Burning/stinging upon insertion | 96.1 score on a scale | Standard Deviation 9.8 |
| LD127025 MF | Symptoms/Complaints | Ease of handling/removal | 89.3 score on a scale | Standard Deviation 16.5 |
| LD127025 MF | Symptoms/Complaints | Dryness | 86.1 score on a scale | Standard Deviation 18.2 |
| LD127025 MF | Symptoms/Complaints | Comfort upon insertion | 95.4 score on a scale | Standard Deviation 8.3 |
| LD127025 MF | Symptoms/Complaints | Comfort at end of day | 83.7 score on a scale | Standard Deviation 19.5 |
| LD127025 MF | Symptoms/Complaints | Overall comfort | 88.3 score on a scale | Standard Deviation 16.4 |
| LD127025 MF | Symptoms/Complaints | Ease of handling/insertion | 92.3 score on a scale | Standard Deviation 13.3 |
| LD127025 MF | Symptoms/Complaints | Itchiness | 94.4 score on a scale | Standard Deviation 10.3 |
| LD127025 MF | Symptoms/Complaints | Redness | 95.3 score on a scale | Standard Deviation 7.6 |
| LD127025 MF | Symptoms/Complaints | Overall impression | 84.1 score on a scale | Standard Deviation 19.7 |
| LD127025 MF | Symptoms/Complaints | Distance vision | 91.0 score on a scale | Standard Deviation 16.1 |
| LD127025 MF | Symptoms/Complaints | Vision at intermediate distance | 80.8 score on a scale | Standard Deviation 21.8 |
| LD127025 MF | Symptoms/Complaints | Vision at near distance | 60.1 score on a scale | Standard Deviation 28.6 |
| LD127025 MF | Symptoms/Complaints | Overall vision | 74.0 score on a scale | Standard Deviation 23 |
| Air Optix Aqua MF | Symptoms/Complaints | Distance vision | 82.0 score on a scale | Standard Deviation 21.1 |
| Air Optix Aqua MF | Symptoms/Complaints | Burning/stinging upon insertion | 93.4 score on a scale | Standard Deviation 11.8 |
| Air Optix Aqua MF | Symptoms/Complaints | Itchiness | 90.2 score on a scale | Standard Deviation 15.1 |
| Air Optix Aqua MF | Symptoms/Complaints | Ease of handling/removal | 93.6 score on a scale | Standard Deviation 9.7 |
| Air Optix Aqua MF | Symptoms/Complaints | Vision at near distance | 76.1 score on a scale | Standard Deviation 22.6 |
| Air Optix Aqua MF | Symptoms/Complaints | Redness | 91.0 score on a scale | Standard Deviation 13.9 |
| Air Optix Aqua MF | Symptoms/Complaints | Comfort upon insertion | 91.4 score on a scale | Standard Deviation 12.6 |
| Air Optix Aqua MF | Symptoms/Complaints | Vision at intermediate distance | 84.4 score on a scale | Standard Deviation 16.3 |
| Air Optix Aqua MF | Symptoms/Complaints | Comfort at end of day | 79.9 score on a scale | Standard Deviation 20.7 |
| Air Optix Aqua MF | Symptoms/Complaints | Overall impression | 83.3 score on a scale | Standard Deviation 19.9 |
| Air Optix Aqua MF | Symptoms/Complaints | Overall comfort | 84.6 score on a scale | Standard Deviation 17.4 |
| Air Optix Aqua MF | Symptoms/Complaints | Overall vision | 79.5 score on a scale | Standard Deviation 19.9 |
| Air Optix Aqua MF | Symptoms/Complaints | Ease of handling/insertion | 93.5 score on a scale | Standard Deviation 9.6 |
| Air Optix Aqua MF | Symptoms/Complaints | Dryness | 85.6 score on a scale | Standard Deviation 16.9 |