Clinical Performance of Stenfilcon A Versus Filcon II 3

NCT01808209 | Completed Results

• 1 other identifier: EX-MKTG-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Performance of Stenfilcon vs. Filcon II 3

Conditions

Myopia

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (7)

• Blood Vessel Coverage

  Baseline

• Blood Vessel Coverage

  1 Week

• Conjunctival Redness

  Baseline

• Conjunctival Redness

  1 Week

• Corneal Staining

  Baseline

Study Arms (2)

stenfilcon A

EXPERIMENTAL

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

filcon II 3

ACTIVE COMPARATOR

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

Interventions

stenfilcon A DEVICE

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Also known as: stenfilcon A (Daily Disposable Contact Lens)

filcon II 3

filcon II 3 DEVICE

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Also known as: filcon II 3 (Daily Disposable Contact Lens)

stenfilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

University of Aston

Birmingham, West Midlands, B4 7ET, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jonathan Walker
• Organization: Opthalmic Research Group, Aston University, Birmingham, UK

JWalker@coopervision.co.uk

Study Officials

• James Wolffsohn, PhD

  University of Aston Birmingham, West Midlands, United Kingdom

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: March 11, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 3, 2020
• Results First Posted: January 19, 2015

Record last verified: 2020-07

Locations

GB (1)