Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses

Not Applicable

Completed

Interventions: Device: Lens A (Hydrogel Daily Disposable Toric Contact Lens)
Device: Lens B (Silicone Hydrogel Daily Disposable Toric Contact Lens)

Brief Summary: This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.

Detailed Description: This was a participant masked, interventional, prospective, direct refit, bilateral wear study. The purpose of this study was to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens after 15 minutes of daily wear each.

Recruitment & Eligibility

Inclusion Criteria

A person was eligible for inclusion in the study if he/she:

Is at least 18 years of age and has full legal capacity to volunteer.
Has read and signed an information consent letter.
Self-reports having a full eye examination in the previous two years.
Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
Is willing and able to follow instructions and maintain the appointment schedule.
Habitual soft contact lens wearers who currently wear toric contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
Has a contact lens spherical prescription between plano to - 10.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
Has refractive astigmatism no less than -0.75D and no more than 1.75D in both eyes.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease.
Has read, understood, and signed the information consent letter.

Exclusion Criteria

A person was excluded from the study if he/she:

Is participating in any concurrent clinical or research study.
Has any known active ocular disease and/or infection that contraindicates contact lens wear.
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
Has known sensitivity to the diagnostic sodium fluorescein used in the study.
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
Has undergone refractive error surgery or intraocular surgery.

Arm && Interventions

Group	Intervention	Description
Lens A	Lens A (Hydrogel Daily Disposable Toric Contact Lens)	Participants will wear Lens A for the first period of 15 minutes.
Lens B	Lens B (Silicone Hydrogel Daily Disposable Toric Contact Lens)	Participants will wear Lens B for the second period of 15 minutes.

Primary Outcome Measures

Name	Time	Method
Subjective Handling at Insertion, Dispensing Visit	15 minutes	Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
Subjecting Handling at Insertion, Follow-up Visit	15 minutes	Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.

Secondary Outcome Measures