A Clinical Comparison of Two Soft Contact Lenses

Not Applicable

Completed

Interventions: Device: Lens 1 (monthly replacement)
Device: Lens 2 (daily disposable)

Brief Summary: The study objective was to gather short-term clinical performance data for two soft contact lenses.

Detailed Description: The aim of this subject-masked, non-randomized, controlled non-dispensing 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.

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 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 (monthly replacement)	All participants wore Lens 1 for 15 minutes (Period 1)
Lens 2	Lens 2 (daily disposable)	All participants wore Lens 2 for 15 minutes (Period 2)

Primary Outcome Measures

Name	Time	Method
Subjective Overall Score	15 minutes	Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall

Secondary Outcome Measures

Name	Time	Method
Subjective Vision	15 minutes	Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss
Subjective Comfort	15 minutes	Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt