Presbyopia
Conditions
Brief summary
The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.
Detailed description
The aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.
Interventions
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
42 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They were at least 42 years of age and had capacity to volunteer. 2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent. 3. They had had a full eye examination within the past two years (by self-report). 4. They were willing and able to follow the protocol. 5. They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months. 6. They had refractive astigmatism of no greater than -0.75DC. 7. They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.
Exclusion criteria
Subjects were not eligible to take part in the study if: 1. They had an ocular disorder which would normally contra-indicate contact lens wear. 2. They had a systemic disorder which would normally contra-indicate contact lens wear. 3. They were using any topical medication such as eye drops or ointment. 4. They were aphakic. 5. They had had corneal refractive surgery. 6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus. 7. They were pregnant or lactating. 8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Score | 15 Minutes | Subjective Overall Score was assessed using the 0-100 visual analogue scale where 0=Extremely poor, cannot use lenses and 100=Excellent=Highly impressed with these lenses overall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort | 15 Minutes | Subjective Comfort Score was assessed using the 0-100 visual analogue scale where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt |
| Subjective Vision | 15 Minutes | Subjective Vision Score (distance and near) was assessed using the 0-100 visual analogue scale where 0=Unacceptable, cannot be worn and 100=Excellent, unaware of any visual loss |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes study participants that completed all study visits | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 6.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 29 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Subjective Overall Score
Subjective Overall Score was assessed using the 0-100 visual analogue scale where 0=Extremely poor, cannot use lenses and 100=Excellent=Highly impressed with these lenses overall
Time frame: 15 Minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Overall Score | 71.4 score on a scale | Standard Deviation 18 |
| Lens 2 | Subjective Overall Score | 80.3 score on a scale | Standard Deviation 14.7 |
Secondary
Subjective Comfort
Subjective Comfort Score was assessed using the 0-100 visual analogue scale where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt
Time frame: 15 Minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Comfort | 75.0 score on a scale | Standard Deviation 20.9 |
| Lens 2 | Subjective Comfort | 88.9 score on a scale | Standard Deviation 12.2 |
Secondary
Subjective Vision
Subjective Vision Score (distance and near) was assessed using the 0-100 visual analogue scale where 0=Unacceptable, cannot be worn and 100=Excellent, unaware of any visual loss
Time frame: 15 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lens 1 | Subjective Vision | Distance Vision | 72.3 score on a scale | Standard Deviation 17.1 |
| Lens 1 | Subjective Vision | Near Vision | 77.4 score on a scale | Standard Deviation 18.2 |
| Lens 2 | Subjective Vision | Distance Vision | 78.4 score on a scale | Standard Deviation 15.8 |
| Lens 2 | Subjective Vision | Near Vision | 79.6 score on a scale | Standard Deviation 15.7 |