Clinical Performance of Stenfilcon A Versus Filcon II 3

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: filcon II 3
Device: stenfilcon A

Registration Number: NCT01808209

Lead Sponsor: Coopervision, Inc.

Brief Summary: Clinical Performance of Stenfilcon vs. Filcon II 3

Detailed Description: The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Subjects must satisfy the following conditions prior to inclusion in the study:

Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.
An existing soft contact lens wearer of any modality.
Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia.
No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection).
No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
No aphakia

Exclusion Criteria

Any of the following will render a subject ineligible for inclusion:

Neophytes, who have not worn lenses before
Greater than 0.75D of refractive astigmatism in either eye
Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
Presence of ocular or systemic disease or need of medication 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 the limbus
Giant papillary conjunctivitis (GPC) Grade 3 or above
Anterior uveitis or iritis (past or present)
Seborrheic eczema, seborrheic conjunctivitis
History of corneal ulcer or fungal infections
Poor personal hygiene
A known history of corneal hypoesthesia (reduced corneal sensitivity).
Contact lens best corrected Snellen visual acuities (VA) worse than 6/9
Aphakia, Keratoconus or a highly irregular cornea

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
stenfilcon A	filcon II 3	Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
filcon II 3	stenfilcon A	Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Primary Outcome Measures

Name	Time	Method
Daily and Comfortable Wearing Time	1 week	Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)
Dryness	1 Week	Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Comfort	1 Week	Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Eye Whiteness	1 Week	Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Overall Satisfaction	1 Week	Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Visual Acuity logMAR	1 Week	Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR
Wettability	1 Week	Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.
Handling	1 Week	Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).
Vision Quality	1 Week	Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)

Secondary Outcome Measures

Name	Time	Method
Blood Vessel Coverage	1 Week	Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.
Corneal Staining	1 Week	Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Conjunctival Staining	1 Week	Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Conjunctival Redness	1 Week	Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.