Myopia, Hyperopia, Contact Lens Comfort
Conditions
Keywords
multi-purpose solution, silicone hydrogel, contact lenses, comfort, Opti-Free, Biotrue
Brief summary
The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS) in silicone hydrogel contact lens wearers.
Detailed description
In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution or Biotrue™ Multipurpose Solution in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.
Interventions
DEVICEBiotrue™ MPS
DEVICEHabitual contact lenses
Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.
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
* Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to Visit 1; * Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on two days during the study; * Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) for at least 30 days prior to Visit 1; * Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1; * Have access, capability and willingness to review and answer text messages; * Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment; * Willing to follow the study procedures and visit schedule; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Need to wear lenses on an extended wear (i.e. overnight) basis during the study; * Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products; * Monocular (only one eye with functional vision) or fit with only one lens; * Wearing toric or multifocal contact lenses or fit with monovision; * Use of additional lens care products other than a Biguanide preserved multipurpose solution such as daily or enzyme cleaners within the one week prior to Visit 1; * Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1; * Abnormal ocular condition observed during the Visit 1 slit-lamp examination; * Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1; * Ocular surgery within the 12 months prior to Visit 1; * Participation in any other clinical trial within 30 days of enrollment; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining | Day 30 | Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed. |
| Change From Baseline in Corneal Staining at Day 30 | Baseline (Day 0), Day 30 | Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed. |
Participant flow
Recruitment details
Participants were recruited from 5 study centers located in the US, 3 study centers located in the UK, and 2 study centers located in Germany.
Pre-assignment details
Of the 207 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (198).
Participants by arm
| Arm | Count |
|---|---|
| PureMoist / Biotrue Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment. | 198 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 30 Days | Adverse Event | 1 | 1 |
| Period 1, First 30 Days | Lost to Follow-up | 1 | 0 |
| Period 1, First 30 Days | Noncompliance | 1 | 0 |
| Period 1, First 30 Days | Withdrawal by Subject | 1 | 0 |
| Period 2, Second 30 Days | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | PureMoist / Biotrue |
|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 11.48 |
| Sex: Female, Male Female | 151 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 196 | 0 / 194 |
| serious Total, serious adverse events | 0 / 196 | 0 / 194 |
Outcome results
Primary
Change From Baseline in Corneal Staining at Day 30
Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Time frame: Baseline (Day 0), Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PureMoist | Change From Baseline in Corneal Staining at Day 30 | 0.7 units on a scale | Standard Deviation 2.59 |
| Biotrue | Change From Baseline in Corneal Staining at Day 30 | 1.6 units on a scale | Standard Deviation 2.91 |
Primary
Corneal Staining
Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Time frame: Day 30
Population: This analysis population group includes all participants who were exposed to both treatment regimens.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PureMoist | Corneal Staining | 1.9 Units on a scale | Standard Deviation 2.3 |
| Biotrue | Corneal Staining | 2.8 Units on a scale | Standard Deviation 2.62 |