Healthy
Conditions
Keywords
Silicone Hydrogel, Soft Contact Lenses, Multi-Purpose Solution
Brief summary
The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers.
Interventions
DEVICEOPTI-FREE PureMoist multipurpose disinfecting solution
FDA-approved, multipurpose disinfecting solution used as indicated for cleaning, rinsing, reconditioning, disinfecting, and storing silicone hydrogel and soft contact lenses on a daily wear basis for 30 days
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Wear silicone hydrogel or traditional soft contact lenses on a daily wear basis, (a minimum of 8 hours per day) for at least one month prior to Visit 1; * Habitual use of a multi-purpose solution containing PHMB for at least 30 days prior to Visit 1; * Vision correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1; * Read, sign, and date IRB-approved informed consent and privacy document; * Be generally healthy and have normal ocular health; * Willing to follow the study procedures and visit schedule; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Wear lenses on an extended wear basis during the study; * Known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products; * Monocular subject; * Requirestoric or multifocal contact lenses; * Use of additional lens care products other than a PHMB multi-purpose 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; * Any abnormal ocular condition observed during the Visit 1 Slit-lamp examination; * Ocular surgery within the 12 months prior to Visit 1; * Use of any systemic medication which has known or expected ocular or systemic side effects at Visit 1, that in the clinical judgment of the investigator, could affect the subject's participation in this study; * Any systemic disease at Visit 1 that may affect the eye or be exacerabated by use of contact lenses or contact lens solutions or which could prevent subjects from wearing their lenses at least 8 hours per day; * Participation in any clinical study within 30 days of Visit 1; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Fluorescein Staining Type at Baseline | Day 0 (Baseline) | Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome. |
| Corneal Fluorescein Staining Type at Day 30 | Day 30 | Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome. |
| Corneal Fluorescein Staining Area at Baseline | Day 0 (Baseline) | Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated \[i.e., 0% (no staining in the region) to 100% (staining covers entire region)\], for a maximum score of 100% per eye. A lower score represents a more desirable outcome. |
| Corneal Fluorescein Staining Area at Day 30 | Day 30 | Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated \[i.e., 0% (no staining in the region) to 100% (staining covers entire region)\], for a maximum score of 100% per eye. A lower score represents a more desirable outcome. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 5 US study centers.
Participants by arm
| Arm | Count |
|---|---|
| OPTI-FREE PureMoist OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days | 124 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | OPTI-FREE PureMoist |
|---|---|
| Age Continuous | 32.2 years STANDARD_DEVIATION 11.39 |
| Region of Enrollment United States | 124 participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 125 |
| serious Total, serious adverse events | 0 / 125 |
Outcome results
Primary
Corneal Fluorescein Staining Area at Baseline
Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated \[i.e., 0% (no staining in the region) to 100% (staining covers entire region)\], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.
Time frame: Day 0 (Baseline)
Population: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPTI-FREE PureMoist | Corneal Fluorescein Staining Area at Baseline | 5.6 Units on a scale | Standard Deviation 9.34 |
Primary
Corneal Fluorescein Staining Area at Day 30
Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated \[i.e., 0% (no staining in the region) to 100% (staining covers entire region)\], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.
Time frame: Day 30
Population: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPTI-FREE PureMoist | Corneal Fluorescein Staining Area at Day 30 | 1.4 Units on a scale | Standard Deviation 2.41 |
Primary
Corneal Fluorescein Staining Type at Baseline
Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
Time frame: Day 0 (Baseline)
Population: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPTI-FREE PureMoist | Corneal Fluorescein Staining Type at Baseline | 1.7 Units on a scale | Standard Deviation 1.38 |
Primary
Corneal Fluorescein Staining Type at Day 30
Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
Time frame: Day 30
Population: Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPTI-FREE PureMoist | Corneal Fluorescein Staining Type at Day 30 | 0.7 Units on a scale | Standard Deviation 0.94 |