The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Optometry Clinic, National Autonomous University
Mexico City, Mexico
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.
Time frame: Baseline (lens insertion), 1 hour
Comfort
Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Time frame: Insertion, 1hr
Lens Centration
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Time frame: Insertion
Lens Centration
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Time frame: 1 Hour
Post-blink Lens Movement
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Time frame: Insertion
Post-blink Lens Movement
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Time frame: 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)
Time frame: 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)
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Time frame: 1 Hour
Lens Fit Preference
Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Time frame: 1 Hour
Limbal Redness
Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)
Time frame: 1 Hour
Bulbar Redness
Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Time frame: 1 Hour