2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.

Official Title
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2-week Dispensing Cross-Over Evaluation of Marketed Silicone Hydrogel Contact Lenses in an Indian Population

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: senofilcon A
* Device: lotrafilcon B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must read, understand English, and sign the Statement of Informed Consent and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be 18 and less than 40 years of age. The subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00D in each eye with visual acuity of 20/25 provided study lenses in each eye. The subject must have less than -1.00 D of cylindrical refraction. The subject must have best corrected visual acuity of 20/25 or better in each eye. The subject must be an adapted soft contact lens wearer in both eyes. The subject must have normal eyes. Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued) Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. Any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.). Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer, or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. Any ocular infections Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment History of binocular vision abnormality or strabismus. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self report. Employee of the investigational clinic (e.g. investigator, Coordinator, Technician)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Test Lens 1<br>senofilcon A (Approved contact lens material) | Device: senofilcon A<br>* One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day<br>Device: lotrafilcon B<br>* One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day<br>|
| Active Comparator: Test Lens 2<br>lotrafilcon B (Approved contact lens material) | Device: senofilcon A<br>* One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day<br>Device: lotrafilcon B<br>* One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Comfort | Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. | 11 days Post fit | 
| Subjective Overall Quality of Vision | Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. | 11 days post fit |