Corneal Staining
Conditions
Keywords
contact lenses, contact lens solution, corneal staining, fluorescein
Brief summary
The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.
Interventions
DEVICEFID 109182
Investigational multipurpose contact lens cleaning and disinfecting solution
DEVICEOpti-Free Plus
Commercially available multipurpose contact lens cleaning and disinfecting solution
Commercially available silicone hydrogel contact lens
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Soft contact lenses habitual wearer, both eyes. * Voluntarily sign Informed Consent. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products. * Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops. * Eye infection, blepharitis, iris inflammation, or severe eye inflammation. * Corneal staining greater than Grade 1 at baseline. * Pregnant, lactating, or intend to become pregnant during study period. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein | Day 1, after 2 hours of wear | The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein | Day 1, after 2 hours of wear | The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale \[0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)\]. Proportion of participants is reported as a percentage. |
Participant flow
Recruitment details
Subjects were enrolled from one study site located in Japan.
Pre-assignment details
Of the 36 subjects enrolled in the study, 8 were exited prior to product exposure \[did not meet eligibility criteria (5), and subject withdrawal (3)\]. This reporting group includes all subjects who used the study products (28).
Participants by arm
| Arm | Count |
|---|---|
| FID 109182/Opti-Free Plus Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | FID 109182/Opti-Free Plus |
|---|---|
| Age, Continuous | 28.0 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment Japan | 28 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.
Time frame: Day 1, after 2 hours of wear
Population: This analysis population includes all subjects who used the study products and had examination/observation data after use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FID 109182 | Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein | 92.6 percentage of participants |
| Opti-Free Plus | Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein | 22.2 percentage of participants |
Secondary
Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein
The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale \[0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)\]. Proportion of participants is reported as a percentage.
Time frame: Day 1, after 2 hours of wear
Population: This analysis population includes all subjects who used the study products and had examination/observation data after use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FID 109182 | Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein | 92.6 percentage of participants |
| Opti-Free Plus | Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein | 44.4 percentage of participants |