Astigmatism
Conditions
Brief summary
The study objective was to gather short-term clinical performance data for two soft toric contact lenses.
Detailed description
This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.
Interventions
DEVICELens 1 (omafilcon B)
Toric daily wear contact lens for 15 minutes
DEVICELens 2 (fanfilcon A)
Toric daily wear contact lens for 15 minutes
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
All participants received Lens 1 and then Lens 2 in fixed-sequence order.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* They are of legal age (18) and capacity to volunteer. * They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. * They are willing and able to follow the protocol. * They currently wear soft contact lenses, or have done so within the past two years. * They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC. * They are expected to be able to be fitted with the study lenses within the power range available.
Exclusion criteria
* They have an ocular disorder which would normally contra-indicate contact lens wear. * They have a systemic disorder which would normally contra-indicate contact lens wear. * They are using any topical medication such as eye drops or ointment. * They are aphakic. * They have had corneal refractive surgery. * They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * They are pregnant or lactating. * They have an eye or health condition including an immunosuppressive or infectious disease which would, 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. * They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Score | 15 minutes | The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort | 15 minutes | Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent. |
| Subjective Vision | 15 minutes | Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes all study participants. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 14.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 25 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Subjective Overall Score
The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Overall Score | 71.6 score on a scale | Standard Deviation 20.2 |
| Lens 2 | Subjective Overall Score | 78.9 score on a scale | Standard Deviation 16.2 |
Secondary
Subjective Comfort
Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Comfort | 74.6 score on a scale | Standard Deviation 19.5 |
| Lens 2 | Subjective Comfort | 85.0 score on a scale | Standard Deviation 15 |
Secondary
Subjective Vision
Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens 1 | Subjective Vision | 76.6 score on a scale | Standard Deviation 19.4 |
| Lens 2 | Subjective Vision | 78.8 score on a scale | Standard Deviation 16.6 |