A Clinical Comparison of Two Soft Contact Lenses
Study Details
Study Description
Brief Summary
The study objective was to gather short-term clinical performance data for two soft contact lenses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The aim of this study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Monthly Replacement Spherical Silicone Hydrogel Contact Lens 1 Subjects will wear Monthly Replacement Silicone Hydrogel Contact Lens 1 for the first period of 15 minutes and Daily Disposable Spherical Silicone Hydrogel Contact Lens 2 for the second period of 15 minutes. |
Device: Monthly Replacement Spherical Silicone Hydrogel Contact Lens 1
Monthly Replacement Spherical Silicone Hydrogel Contact Lens 1 - first period of 15 minutes
|
| Experimental: Daily Disposable Silicone Hydrogel Contact Lens 2 Subjects will wear Daily Disposable Spherical Silicone Hydrogel Contact Lens 2 for the second period of 15 minutes. |
Device: Daily Disposable Spherical Silicone Hydrogel Contact Lens 2
Daily Disposable Spherical Silicone Hydrogel Contact Lens 2 - second period of 15 minutes
|
Outcome Measures
Primary Outcome Measures
- Subjective Overall Score [15 minutes]
Subjective overall score will be assessed using 0-100 visual analogue scale (0=Extremely poor. Cannot use lenses. and 100=Excellent. Highly impressed with these lenses overall.)
Secondary Outcome Measures
- Subjective Comfort [15 minutes]
Subjective comfort score will be assessed using 0-100 visual analogue scale (0=Causes pain. Cannot be tolerated.; 100=Excellent. Cannot be felt.)
- Subjective Vision [15 minutes]
Subjective vision score will be assessed using 0-100 visual analogue scale (0=Unacceptable. Lens cannot be worn.; 100=Excellent. Unaware of any visual loss.)
Eligibility Criteria
Criteria
Inclusion Criteria:
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They are of legal age (18) and 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 within the past two years.
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They are expected to be able to be fitted with the study lenses within the power range available.
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 lactating.
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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.
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They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eurolens Research | Manchester | United Kingdom |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: Philip Morgan, PhD, MCOptom, Eurolens Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C22-724 (EX-MKTG-138)