Status:
COMPLETED
Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).
Detailed Description
This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separ...
Eligibility Criteria
Inclusion
- They are of aged 18-40 and have 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 agree not to participate in other clinical research for the duration of this study.
- They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
- They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).
- They can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They currently use soft contact lenses or have done so in the previous six months.
Exclusion
- 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 have had cataract surgery.
- 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 any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- 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.
- They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Key Trial Info
Start Date :
June 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03235115
Start Date
June 23 2017
End Date
September 22 2017
Last Update
September 12 2019
Active Locations (1)
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1
Eurolens Research - The University of Manchester
Manchester, United Kingdom, M13 9PL