Clinical Evaluation of Two Toric Contact Lenses

Study Overview
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Brief Summary
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The study objective was to compare short-term clinical performance data of two toric contact lenses.

Detailed Description
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The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of a monthly toric contact lens when compared to a daily disposable toric contact lens after 15 minutes of daily wear each.

Official Title
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Clinical Evaluation of Clariti Monthly Toric and Clariti 1 Day Toric

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Lens A
* Device: Lens B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between 18 and 40 years of age (inclusive) Has had a self-reported visual exam in the last two years Is an adapted soft contact lens wearer Is not a habitual wearer of either study lens Has a contact lens spherical prescription between +4.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25 D 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. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so). Is willing to comply with the visit schedule Exclusion Criteria: Has a CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 2-4) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants received Lens A and then Lens B in fixed-sequence order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens A<br>All participants wore Lens A for 15 minutes (Period 1) | Device: Lens A<br>* Monthly Replacement Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear<br>|
| Experimental: Lens B<br>All participants wore Lens B for 15 minutes (Period 2) | Device: Lens B<br>* Daily Disposable Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Handling Ratings on Insertion | Subjective handling ratings on insertion will be measured on a scale from 0-100, where (0= extremely uncomfortable) and 100 = better performance | At insertion |