Evaluation of Rotation With a Multifocal Toric Contact Lens

Study Overview
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Brief Summary
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The study is a bilateral, single-masked, single-visit, non-dispensing 2x2 crossover study to confirm a finalized design of a prototype contact lens. There will be eight study lens types, however, each subject will only be randomized to receive two study lens types.

Official Title
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Evaluation of Rotation With a Multifocal Toric Contact Lens

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: Test Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Be at least 40 and not more than 70 years of age at the time of screening. Own a wearable pair of spectacles with distance vision correction. Be an adapted soft contact lens wearer in both eyes (i.e. has worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for the past four weeks). Have distance spherical equivalent refraction in the range of either -1.00 D to -6.00 D or +1.00 to +6.00 D in each eye. Have distance cylinder refraction in the range of -0.75 to - 2.50 D in each eye, with the axis being in the range of either 90 ± 30° or 180 ± 30°. Have best corrected distance visual acuity of 20/25 or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Be currently pregnant or lactating. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). Use systemic medications that may interfere with contact lens wear or cause blurred vision. See section 9.1 for additional details regarding excluded systemic medications. Currently use ocular medication with the exception of rewetting drops. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops, or sodium fluorescein. Have had any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). Have a history of amblyopia or strabismus. Have a history of herpetic keratitis. Have a history of irregular cornea. Have a history of pathological dry eye. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear. Have entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions. Have any current ocular infection or inflammation. Have any other ocular abnormality that may interfere with contact lens wear

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myopes - Against the Rule Sequence 1<br>Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, against-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. | Device: Test Lens<br>* Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter<br>|
| Experimental: Myopes - Against the Rule Sequence 2<br>Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, against-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. | Device: Test Lens<br>* Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter<br>|
| Experimental: Myopes - With the Rule Sequence 1<br>Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, with-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. | Device: Test Lens<br>* Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter<br>|
| Experimental: Myopes - With the Rule Sequence 2<br>Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, with-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. | Device: Test Lens<br>* Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter<br>|
| Experimental: Hyperopes - Against the Rule Sequence 1<br>Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, against-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. | Device: Test Lens<br>* Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter<br>|
| Experimental: Hyperopes - Against the Rule Sequence 2<br>Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, against-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at time bilaterally over 2 wear periods. | Device: Test Lens<br>* Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter<br>|
| Experimental: Hyperope - With the Rule Sequence 1<br>Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, with-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. | Device: Test Lens<br>* Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter<br>|
| Experimental: Hyperope - With the Rule Sequence 2<br>Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, with-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. | Device: Test Lens<br>* Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Eyes With Absolute Rotation ≤ 10 Degrees | Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens. | 15-minutes post lens insertion |