Conjunctival Staining
Conditions
Keywords
Conjunctival Staining, lens parameters, lens fit
Brief summary
The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.
Interventions
DEVICEComplete Easy Rub
Commercially marketed contact lens solution for contact lens care
DEVICEReNu MultiPlus
Commercially marketed contact lens solution for contact lens care
DEVICEClear Care
Commercially marketed contact lens solution for contact lens care
DEVICEContact lenses
Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully wearing hydrogel and/or silicone hydrogel contact lenses; * Read, sign, and date informed consent/HIPAA document; * Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles; * Willing and able to discontinue contact lens wear when requested during the study; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Evidence or history of ocular disease or pathology; * One functional eye or a monofit lens; * Use of concomitant topical ocular prescription or over-the-counter ocular medications; * History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Circumlimbal Conjunctival Staining Score | 1 week | Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week | Dispense (Day 0), 1 week | Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve. |
| Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week | Dispense (Day 0), 1 week | Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter. |
Countries
United States
Participant flow
Pre-assignment details
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 1 week before switching to the next assigned product. A 36-hour washout preceded each usage period.
Participants by arm
| Arm | Count |
|---|---|
| Overall Baseline characteristics are presented for all participants completing all three treatment sequences. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| First Week of Wear | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| First Week of Wear | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 41.6 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 1 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Mean Circumlimbal Conjunctival Staining Score
Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.
Time frame: 1 week
Population: This reporting group includes all participants who completed all study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReNu MultiPlus | Mean Circumlimbal Conjunctival Staining Score | 6.39 Units on a scale | Standard Deviation 2.3 |
| Complete Easy Rub | Mean Circumlimbal Conjunctival Staining Score | 5.55 Units on a scale | Standard Deviation 2.94 |
| Clear Care | Mean Circumlimbal Conjunctival Staining Score | 5.68 Units on a scale | Standard Deviation 1.91 |
Secondary
Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week
Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.
Time frame: Dispense (Day 0), 1 week
Population: This reporting group includes all participants who completed all study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReNu MultiPlus | Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week | -0.25 mm | Standard Deviation 0.16 |
| Complete Easy Rub | Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week | -0.27 mm | Standard Deviation 0.17 |
| Clear Care | Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week | -0.25 mm | Standard Deviation 0.15 |
Secondary
Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week
Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.
Time frame: Dispense (Day 0), 1 week
Population: This reporting group includes all participants who completed all study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReNu MultiPlus | Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week | 0.15 mm | Standard Deviation 0.1 |
| Complete Easy Rub | Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week | 0.13 mm | Standard Deviation 0.11 |
| Clear Care | Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week | 0.14 mm | Standard Deviation 0.1 |