A Clinical Performance of Two Soft Toric Contact Lenses

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Lens 1	Lens 1 (omafilcon B)	All participants wore Lens 1 for 15 minutes (Period 1)
Lens 2	Lens 2 (fanfilcon A)	All participants wore Lens 2 for 15 minutes (Period 2)

Primary Outcome Measures

Name	Time	Method
Subjective Overall Score	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 Outcome Measures

Name	Time	Method
Subjective Vision	15 minutes	Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent.
Subjective Comfort	15 minutes	Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent.