Refractive Errors, Ametropia
Conditions
Brief summary
The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.
Detailed description
In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.
Interventions
DEVICEContact lens with investigational coating 1
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
DEVICEContact lens with investigational coating 2
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and must sign an Informed Consent; * Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * Manifest cylinder less than or equal to 1.50 diopter (D) in each eye; * Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye; * VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated; * History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye; * Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; * Current or history of pathologically dry eye in either eye that would preclude contact lens wear; * Current or history of herpetic keratitis in either eye; * Eye injury in either eye within 12 weeks immediately prior to enrollment; * History of intolerance or hypersensitivity to any component of the study lenses or solutions; * Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Percent Area of Solution-related Corneal Staining | Day 1 after 2 hours of wear, each product | Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in the United States (US).
Pre-assignment details
All 33 subjects enrolled were randomized. This reporting group includes all randomized subjects (33).
Participants by arm
| Arm | Count |
|---|---|
| Overall Contact lens with investigational coatings and balafilcon A contact lens worn contralaterally during Period 1 and Period 2. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 14.46 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 27 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 0 / 33 |
Outcome results
Primary
Average Percent Area of Solution-related Corneal Staining
Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.
Time frame: Day 1 after 2 hours of wear, each product
Population: This analysis population includes all randomized subjects who satisfied protocol-specified criteria (Full Analysis Set).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 1 | Average Percent Area of Solution-related Corneal Staining | 7.01 percentage of area | Standard Deviation 10.54 |
| Control 1 | Average Percent Area of Solution-related Corneal Staining | 12.82 percentage of area | Standard Deviation 17.93 |
| Test 2 | Average Percent Area of Solution-related Corneal Staining | 13.54 percentage of area | Standard Deviation 17.2 |
| Control 2 | Average Percent Area of Solution-related Corneal Staining | 7.58 percentage of area | Standard Deviation 10.34 |