Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

Study Overview
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Brief Summary
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The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

Detailed Description
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This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.

Official Title
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Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.

Conditions
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Myopia

Intervention / Treatment
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* Device: Omafilcon A
* Device: Somofilcon A
* Device: Omafilcon A - Proclear (PC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: 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 CL (Contact Lens) wearer who is not wearing any of the study lenses. Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive) Has a spectacle cylinder up to 0.75D (Diopter) in each eye. 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. Is willing to comply with the visit schedule. Exclusion Criteria: A person will be excluded from the study if he/she: Has never worn contact lenses before. Currently wears rigid gas permeable contact lenses. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has a CL prescription outside the range of - 1.00 to - 6.00D Has a spectacle cylinder ≥1.00D of cylinder in either eye. 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omafilcon A<br>Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study. | Device: Omafilcon A<br>* contact lens<br>|
| Active Comparator: Somofilcon A<br>Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study. | Device: Somofilcon A<br>* contact lens<br>|
| Active Comparator: Omafilcon A - Proclear (PC)<br>Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study. | Device: Omafilcon A - Proclear (PC)<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed. | Baseline (lens insertion), 1 hour | 
| Comfort | Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable) | Insertion, 1hr | 
| Lens Centration | Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable) | Insertion | 
| Lens Centration | Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable) | 1 Hour | 
| Post-blink Lens Movement | Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive) | Insertion | 
| Post-blink Lens Movement | Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive) | 1 Hour | 
| Lens Fit Acceptance | Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect) | Insertion | 
| Lens Fit Acceptance | Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect) | 1 Hour | 
| Lens Fit Preference | Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC)) | 1 Hour | 
| Limbal Redness | Redness of limbal area (Scale: 0-4, 0 = none, 4=severe) | 1 Hour | 
| Bulbar Redness | Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe) | 1 Hour |