Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Acuity Using logMAR
Study Overview
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 separate study days in random order. Lenses will only be worn during study visits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 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 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.
Arms & Interventions
Methafilcon A IV
Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.
Intervention: Ocufilcon B (Device)
Methafilcon A IV
Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.
Intervention: Omafilcon A (Device)
Ocufilcon B
Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.
Intervention: Methafilcon A IV (Device)
Ocufilcon B
Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.
Intervention: Omafilcon A (Device)
Omafilcon A
Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.
Intervention: Methafilcon A IV (Device)
Omafilcon A
Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.
Intervention: Ocufilcon B (Device)
Outcomes
Primary Outcomes
Visual Acuity Using logMAR
Time Frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
Lens Fit - Horizontal Centration
Time Frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of horizontal centration of lens on eye
Lens Fit - Vertical Centration
Time Frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of vertical centration of lens on eye
Lens Fit - Corneal Coverage of Lens
Time Frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of corneal coverage of lens on eye
Lens Fit - Movement of Lens
Time Frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of movement of lens on eye
Secondary Outcomes
No secondary outcomes reported