Contact Lens Fit, Myopia
Conditions
Keywords
Contact Lens Wear, Contact Lens Solution, Multi-purpose disinfecting solution, Myopia
Brief summary
The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
Interventions
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
DEVICEGalyfilcon A contact lenses (Acuvue Advance)
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1. * Wear contact lenses a minimum of 8 hours per day prior to Visit 1. * Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study. * Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable. * History of intolerance or known sensitivity to any component of the treatments. * Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit | Day 14 of lens wear | As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score | Day 14 of lens wear | The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16. |
Participant flow
Recruitment details
Subjects were recruited from 5 US study centers.
Participants by arm
| Arm | Count |
|---|---|
| FID 114576A / Renu Fresh FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days. | 44 |
| Renu Fresh / FID 114675A Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days. | 45 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period Two, 14 Days of Wear | Adverse Event | 0 | 1 |
| Period Two, 14 Days of Wear | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | FID 114576A / Renu Fresh | Renu Fresh / FID 114675A | Total |
|---|---|---|---|
| Age Continuous | 34.3 years STANDARD_DEVIATION 11.44 | 31.4 years STANDARD_DEVIATION 9.71 | 32.8 years STANDARD_DEVIATION 10.64 |
| Sex: Female, Male Female | 31 Participants | 30 Participants | 61 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 89 | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 | 0 / 89 |
Outcome results
Primary
Lens Fit
As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
Time frame: Day 14 of lens wear
Population: Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FID 114576A | Lens Fit | 100 percentage of acceptable fit |
| Renu Fresh | Lens Fit | 100 percentage of acceptable fit |
Secondary
Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.
Time frame: Day 14 of lens wear
Population: Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 114576A | Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score | 0.6 units on a scale | Standard Deviation 2.49 |
| Renu Fresh | Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score | 1.4 units on a scale | Standard Deviation 2.63 |