Astigmatism, Myopia
Conditions
Brief summary
The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.
Detailed description
This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.
Interventions
DEVICETest Contact lens
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
DEVICEControl Contact lens
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. They are aged 18-35 years and have capacity to volunteer. 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They are an existing wearer of soft spherical contact lenses in both eyes. 5. They have a spherical component of their spectacle refractive error between -0.50DS and -6.50DS in both eyes. 6. They have a cylindrical component of their spectacle refractive error between -0.75DC and -1.25DC in both eyes. 7. They can be fitted satisfactorily with both lens types. 8. They own an acceptable pair of spectacles. 9. They agree not to participate in other clinical research for the duration of the study.
Exclusion criteria
1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis. 4. They are aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They are pregnant or breastfeeding. 8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. 10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision Stability While Doing Tasks on Mobile Phone | 30 minutes | Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) |
| Vision Stability While Doing Tasks on Desktop | 30 minutes | Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) |
| Vision Stability While Walking | 30 minutes | Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit for Test Contact Lens | 10 minutes | Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°. |
| Lens Fit | 30 minutes | Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear either test or control lenses for 30 minutes and then cross-over to the other lens. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 27 Participants | — |
| Age, Continuous | 28.7 years STANDARD_DEVIATION 7.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 27 participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Vision Stability While Doing Tasks on Desktop
Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Vision Stability While Doing Tasks on Desktop | 87.78 units on a scale | Standard Deviation 12.04 |
| Control Contact Lens | Vision Stability While Doing Tasks on Desktop | 83.41 units on a scale | Standard Deviation 15.13 |
Primary
Vision Stability While Doing Tasks on Mobile Phone
Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Vision Stability While Doing Tasks on Mobile Phone | 88.37 units on a scale | Standard Deviation 10.71 |
| Control Contact Lens | Vision Stability While Doing Tasks on Mobile Phone | 85.30 units on a scale | Standard Deviation 11.75 |
Primary
Vision Stability While Walking
Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Vision Stability While Walking | 88.15 units on a scale | Standard Deviation 14.77 |
| Control Contact Lens | Vision Stability While Walking | 82.63 units on a scale | Standard Deviation 15.22 |
Secondary
Lens Fit
Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator.
Time frame: 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Contact Lens | Lens Fit | Acceptable | 27 participants |
| Test Contact Lens | Lens Fit | Not Acceptable | 0 participants |
| Control Contact Lens | Lens Fit | Acceptable | 27 participants |
| Control Contact Lens | Lens Fit | Not Acceptable | 0 participants |
Secondary
Lens Fit for Test Contact Lens
Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°.
Time frame: 10 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Contact Lens | Lens Fit for Test Contact Lens | 0° | 8 Number of Lenses |
| Test Contact Lens | Lens Fit for Test Contact Lens | 1-5° | 16 Number of Lenses |
| Test Contact Lens | Lens Fit for Test Contact Lens | 6-10° | 2 Number of Lenses |
| Test Contact Lens | Lens Fit for Test Contact Lens | 11-15° | 1 Number of Lenses |
| Test Contact Lens | Lens Fit for Test Contact Lens | 16-20° | 0 Number of Lenses |
| Test Contact Lens | Lens Fit for Test Contact Lens | More than 20° | 0 Number of Lenses |
| Control Contact Lens | Lens Fit for Test Contact Lens | 16-20° | 0 Number of Lenses |
| Control Contact Lens | Lens Fit for Test Contact Lens | 0° | 9 Number of Lenses |
| Control Contact Lens | Lens Fit for Test Contact Lens | 11-15° | 1 Number of Lenses |
| Control Contact Lens | Lens Fit for Test Contact Lens | 1-5° | 17 Number of Lenses |
| Control Contact Lens | Lens Fit for Test Contact Lens | More than 20° | 0 Number of Lenses |
| Control Contact Lens | Lens Fit for Test Contact Lens | 6-10° | 0 Number of Lenses |