NCT05633082CompletedNot Applicable
A Clinical Performance of Two Soft Toric Contact Lenses
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Subjective Overall Score
Study Overview
Brief Summary
The study objective was to gather short-term clinical performance data for two soft toric contact lenses.
Detailed Description
This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •They are of legal age (18) and 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 currently wear soft contact lenses, or have done so within the past two years.
- •They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
- •They are expected to be able to be fitted with the study lenses within the power range available.
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 are aphakic.
- •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 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.
- •They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Arms & Interventions
Lens 1
Experimental
All participants wore Lens 1 for 15 minutes (Period 1)
Intervention: Lens 1 (omafilcon B) (Device)
Lens 2
Experimental
All participants wore Lens 2 for 15 minutes (Period 2)
Intervention: Lens 2 (fanfilcon A) (Device)
Outcomes
Primary Outcomes
Subjective Overall Score
Time Frame: 15 minutes
The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.
Secondary Outcomes
- Subjective Vision(15 minutes)
- Subjective Comfort(15 minutes)
Investigators
Study Sites (1)
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