Clinical Performance of Stenfilcon A Versus Filcon II 3

Clinical Performance of Stenfilcon vs. Filcon II 3

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: filcon II 3; Device: stenfilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B4 7ET
      • University of Aston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: filcon II 3 (Daily Disposable Contact Lens)
Active Comparator: 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.	Device: 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.; Other Names: stenfilcon A (Daily Disposable Contact Lens)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily and Comfortable Wearing Time	Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)	Baseline
Daily and Comfortable Wearing Time	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.)	1 week
Handling	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).	1 Week
Comfort	Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)	Baseline
Comfort	Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).	1 Week
Dryness	Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)	Baseline
Dryness	Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).	1 Week
Vision Quality	Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)	Baseline
Vision Quality	Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)	1 Week
Eye Whiteness	Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).	Baseline
Eye Whiteness	Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).	1 Week
Overall Satisfaction	Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).	Baseline
Overall Satisfaction	Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).	1 Week
Visual Acuity logMAR	Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.	Baseline
Visual Acuity logMAR	Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.	Dispense
Visual Acuity logMAR	Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR	1 Week
Wettability	Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.	1 Week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: James Wolffsohn, PhD, University of Aston Birmingham, West Midlands, United Kingdom

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 14, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-40