Contact Lens Solutions
Conditions
Keywords
Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film
Brief summary
The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.
Interventions
soft contact lens disinfecting solution
DEVICEReNu MultiPlus®
soft contact lens disinfecting solution
Sponsors
Alcon Research
Manhattan Vision Associates
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must be at least 18 years of age and no more than 80 years of age. 2. The subject must have a best corrected visual acuity of 20/30 or better for each eye. 3. The subject must habitually wear contact lenses. 4. The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit. 5. The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation. 6. The subject must read understand and sign the Statement of Informed Consent. 7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion criteria
1. Ocular or systemic allergies or disease that might interfere with contact lens wear. 2. Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear. 3. Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear. 4. Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 5. Any ocular infection. 6. Pregnancy or lactation. 7. Diabetes 8. Infectious diseases (e.g. hepatitis, tuberculosis) 9. Contagious immunosuppressive diseases (e.g. HIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective, In-vivo Soft Contact Lens Wettability Index | 2 weeks | The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Questionnaire Response | 2 weeks | Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent |
Countries
United States
Participant flow
Recruitment details
Recruitment of patients was conducted by approaching the patients seen in the practice.
Pre-assignment details
32 subjects were recruited and enrolled in the study. No subjects had to be excluded.
Participants by arm
| Arm | Count |
|---|---|
| 1 - ReNu MultiPlus First Used ReNu MultiPlus first, Opti-Free RepleniSH Second | 16 |
| 2 - Opti-Free RepleniSH First Opti-Free RepleniSH first, ReNu MultiPlus Second | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other Reason | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 2 - Opti-Free RepleniSH First | 1 - ReNu MultiPlus First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Age Continuous | 27.4 years STANDARD_DEVIATION 5.1 | 27.3 years STANDARD_DEVIATION 3.8 | 27.3 years STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Objective, In-vivo Soft Contact Lens Wettability Index
The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.
Time frame: 2 weeks
Population: Per protocol. All participants that completed both arms were analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opti-Free® RepleniSH® MPDS | Objective, In-vivo Soft Contact Lens Wettability Index | -1.82 wettability index | Standard Deviation 2.88 |
| Renu MultiPlus® | Objective, In-vivo Soft Contact Lens Wettability Index | -1.98 wettability index | Standard Deviation 2.8 |
Secondary
Subject Questionnaire Response
Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opti-Free® RepleniSH® MPDS | Subject Questionnaire Response | 42.7 units on a scale | Standard Deviation 7.3 |
| Renu MultiPlus® | Subject Questionnaire Response | 43.1 units on a scale | Standard Deviation 5 |