Clinical Performance of Stenfilcon A Versus Filcon II 3

NCT ID: NCT01808209

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-05-31

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

filcon II 3

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

stenfilcon A

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

stenfilcon A (Daily Disposable Contact Lens); filcon II 3 (Daily Disposable Contact Lens)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Wolffsohn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aston Birmingham, West Midlands, United Kingdom

Locations

University of Aston

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

Other Identifiers

EX-MKTG-40

Identifier Type: -

Identifier Source: org_study_id