Contact Lens Wear
Conditions
Keywords
Soft Contact lens, Multi-purpose solution, Wettability
Brief summary
The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.
Interventions
DEVICEBiotrue multipurpose solution
Contact lens care solution
DEVICESauflon Synergi multipurpose solution
Contact lens care solution
DEVICEOTE Elements multipurpose solution
Contact lens care solution
DEVICESilicone hydrogel contact lenses (Acuvue Advance)
Commercially marketed contact lenses
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age * Soft contact lens wear on a daily wear basis * Able to wear lenses at least 8 hours * Generally healthy with normal ocular health * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Use of additional lens cleaners * Known sensitivities to any ingredient in any of the study products * History of ocular surgery/trauma within the last 6 months * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ex Vivo Contact Angle | 8 hours | Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort | 8 hours | Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged. |
| Corneal Staining Type | 8 hours | Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged. |
| Corneal Staining Extent | 8 hours | Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged. |
Participant flow
Recruitment details
Participants were recruited and enrolled from one Canadian study center.
Participants by arm
| Arm | Count |
|---|---|
| Overall All enrolled participants | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1, 8 Hours | Personal Reasons | 0 | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 24.8 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 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 / 21 | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 20 |
Outcome results
Primary
Ex Vivo Contact Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.
Time frame: 8 hours
Population: This reporting group includes all participants who completed the study, minus one response in Synergi group due to a measurement error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synergi | Ex Vivo Contact Angle | 104.8 degrees | Standard Deviation 2.4 |
| Bio-True | Ex Vivo Contact Angle | 104.9 degrees | Standard Deviation 3.7 |
| OTE Elements | Ex Vivo Contact Angle | 103.3 degrees | Standard Deviation 5.4 |
Secondary
Corneal Staining Extent
Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.
Time frame: 8 hours
Population: This reporting group includes all participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synergi | Corneal Staining Extent | 0.7 percentage of cornea | Standard Deviation 0.8 |
| Bio-True | Corneal Staining Extent | 3.1 percentage of cornea | Standard Deviation 3.8 |
| OTE Elements | Corneal Staining Extent | 0.9 percentage of cornea | Standard Deviation 4.7 |
Secondary
Corneal Staining Type
Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.
Time frame: 8 hours
Population: This reporting group includes all participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synergi | Corneal Staining Type | 5.4 Units on a scale | Standard Deviation 8.4 |
| Bio-True | Corneal Staining Type | 8.8 Units on a scale | Standard Deviation 8.4 |
| OTE Elements | Corneal Staining Type | 3.0 Units on a scale | Standard Deviation 4.7 |
Secondary
Subjective Comfort
Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.
Time frame: 8 hours
Population: This reporting group includes all participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synergi | Subjective Comfort | 87.3 Units on a scale | Standard Deviation 7.9 |
| Bio-True | Subjective Comfort | 87.3 Units on a scale | Standard Deviation 10.2 |
| OTE Elements | Subjective Comfort | 86.4 Units on a scale | Standard Deviation 15 |