The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
Study Details
Study Description
Brief Summary
This study aims to compare the clinical performance of two daily disposable toric contact lenses.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This will be a multi-centre, randomised, open-label, crossover, bilateral study, controlled by cross-comparison. Up to 55 subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear.
Lenses will be worn on a daily wear, daily disposable wear schedule.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lens A (Test) Subjects will be randomized to wear Lens A (Test) toric lens for one week. |
Device: Lens A (Test)
Test toric lens
Device: Lens B (control)
Control toric lens
|
Active Comparator: Lens B (Control) Subjects will be randomized to wear Lens B (control) toric lens for one week. |
Device: Lens A (Test)
Test toric lens
Device: Lens B (control)
Control toric lens
|
Outcome Measures
Primary Outcome Measures
- Subjective handling ratings on lens removal [One week.]
Subjective handling ratings on lens removal will be measured on a scale of 0-100 (0- Unmanageable, 20- Very poor , 40 - Poor, 60- Good, 80- Very good, 100- Excellent unsuccessful removal, 40 -
Secondary Outcome Measures
- Lens Fit - Horizontal Centration [One Week]
Lens Fit - Horizontal Centration will be measured on a five point scale -2 to +2 (-2 Extremely nasal, -1 Slightly nasal, 0 = Optimum, +1 Slightly temporal, +2 Extremely temporal)
- Lens Fit - Vertical centration [One week]
Lens Fit - Vertical Centration will be measured on a five point scale of -2 to +2 (-2 Extremely inferior, -1 Slightly inferior, 0= Optimum, +1 Slightly Superior, +2 Extremely Superior)
- Corneal Coverage [One week]
Corneal Coverage will be measured on a five point scale 0f -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)
- Lens Movement [One week]
Lens Movement will be measured on a five point scale of -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)
Eligibility Criteria
Criteria
Inclusion Criteria:
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They are aged between 18 and 40 years and have capacity to volunteer.
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They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
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They are willing and able to follow the protocol.
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They currently wear soft contact lenses or have done so in the past two years.
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They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
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They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
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They can be satisfactorily fitted with the study lens types.
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At dispensing, they can attain at least 6/12 distance high contrast visual acuity in each eye with the study lenses within the available power range.
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They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
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They own a wearable pair of spectacles.
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They agree not to participate in other clinical research while enrolled on this study.
Exclusion Criteria:
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They have an ocular disorder which would normally contra-indicate contact lens wear.
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They have a systemic disorder, which would normally contra-indicate contact lens wear.
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They are using any topical medication such as eye drops or ointment.
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They are aphakic.
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They have had corneal refractive surgery.
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They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
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They are pregnant or breastfeeding.
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They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
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They have eye or health conditions including immunosuppressive or infectious diseases, 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.
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They are currently wearing one of the study contact lenses.
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They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cameron Optometry | Edinburgh | Edinburg | United Kingdom | EH3 6SW |
2 | Simon Falk Eyecare | Oakwood | Leeds | United Kingdom | LS8 2HU |
3 | Phipps Opticians | Heckmondwike | United Kingdom | WF16 0EZ |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: Philip Morgan, Eurolens Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C20-691 (EX-MKTG-121)