Presbyopia
Conditions
Keywords
Contact lens induced dryness
Brief summary
The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.
Interventions
DEVICE3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix
For cleaning, disinfection and overnight storage of contact lenses
DEVICEHabitual Contact Lenses
Participant's habitual contact lens brand worn in a daily wear modality for 30 days.
Sponsors
Alcon, a Novartis Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must sign an informed consent document; * Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness; * Near spectacle add of +0.50 or greater; * Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance; * Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits; * Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose solution (OPTI-FREE® PureMoist® is excluded) to care for lenses; * Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study; * Other protocol-specific inclusion criteria may apply.
Exclusion criteria
* Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week); * Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP); * Prior refractive surgery; * History of herpetic keratitis, ocular surgery, or irregular cornea; * Pathological dry eye that precludes contact lens wear; * Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; * Participation in any clinical study within 30 days of Visit 1; * Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days; * Other protocol-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30 | Day 30, each product | CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms. |
Participant flow
Recruitment details
Subjects were recruited from 9 study centers located in the United States.
Pre-assignment details
Of the 126 enrolled, 5 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (121).
Participants by arm
| Arm | Count |
|---|---|
| Overall 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix and subject's HMPS used during Period 1 and Period 2 in a crossover assignment. | 121 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 30 Days of Wear | Adverse Event | 0 | 1 |
| Period 1, First 30 Days of Wear | Lost to Follow-up | 1 | 1 |
| Period 1, First 30 Days of Wear | Protocol Violation | 1 | 0 |
| Period 1, First 30 Days of Wear | Withdrawal by Subject | 1 | 0 |
| Period 2, Second 30 Days of Wear | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 5.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 103 Participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 121 |
| other Total, other adverse events | 0 / 121 | 0 / 121 |
| serious Total, serious adverse events | 0 / 121 | 1 / 121 |
Outcome results
Primary
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
Time frame: Day 30, each product
Population: Full Analysis Set with non-missing responses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLEAR CARE PLUS | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30 | 12.6 units on a scale | Standard Deviation 7.19 |
| HMPS | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30 | 14.8 units on a scale | Standard Deviation 7.99 |
p-value: =0.0073Mixed Models Analysis