Study Focus is Healthy Contact Lens Wearers
Conditions
Keywords
adapted contact lens wearers
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.
Detailed description
A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.
Interventions
DEVICEInvestigational MPS
Multi-purpose solution
DEVICEOpti-Free
Multi-purpose solution
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have successfully worn hydrogel contact lenses of the same material to be worn during the study * Have normal eyes (with the exception of unaided visual acuity) * Have successfully used a multi-purpose contact lens care solution * Have acceptable visual acuity and lens wearing comfort at time of enrollment
Exclusion criteria
* Concurrently enrolled another clinical trial * Have a known sensitivity to any study product ingredient(s) * Have a condition that may put them at significant risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Lens Cleanliness as Measured by Light Reflectance | Day 30 | Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With no Corneal Staining | Day 180 | Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein. |
Countries
United States
Participant flow
Recruitment details
Subjects for this study were chosen from the normal hydrogel contact lens-wearing patient populations at each of the investigational sites according to the following inclusion and exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Investigational MPS Investigational multipurpose disinfecting solution (study MPS) | 177 |
| Predicate MPS Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) | 93 |
| Total | 270 |
Baseline characteristics
| Characteristic | Investigational MPS | Predicate MPS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 177 Participants | 93 Participants | 270 Participants |
| Region of Enrollment United States | 177 participants | 93 participants | 270 participants |
| Sex: Female, Male Female | 118 Participants | 65 Participants | 183 Participants |
| Sex: Female, Male Male | 59 Participants | 28 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 177 | 12 / 93 |
| serious Total, serious adverse events | 0 / 177 | 0 / 93 |
Outcome results
Primary
Mean Lens Cleanliness as Measured by Light Reflectance
Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).
Time frame: Day 30
Population: Lens cleanliness analysis could only be done on subjects whose lenses were returned for analysis. Out of 270 subjects, 253 returned their study lenses to the sponsor for lab analysis (169 + 84 = 253).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational MPS | Mean Lens Cleanliness as Measured by Light Reflectance | 65.5 light reflectance score | Standard Deviation 13.92 |
| Predicate MPS | Mean Lens Cleanliness as Measured by Light Reflectance | 66.8 light reflectance score | Standard Deviation 14.95 |
Secondary
Number of Subjects With no Corneal Staining
Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.
Time frame: Day 180
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational MPS | Number of Subjects With no Corneal Staining | 129 participants |
| Predicate MPS | Number of Subjects With no Corneal Staining | 64 participants |