Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users

NCT01180998 | Completed Results FDA Device

• 1 other identifier: CR-201004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 18

Brief Summary

The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact lenses (neophytes).

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (3)

• Overall Success in Fitting With a Toric Contact Lens

  Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.

  4 weeks

• Distance Visual Acuity

  Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.

  after 1 week of toric contact lens wear

• Distance Visual Acuity (VA)

  Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.

  after 4 weeks of toric contact lens wear

Study Arms (3)

Spherical contact lens users

OTHER

Habitual spherical contact lens (non-toric lens) users tried one of two toric lenses in a daily wear modality.

Device: Senofilcon A Toric (AOfA); Device: Etafilcon A Toric (1DAMfA)

Contact lens drop-outs

OTHER

Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, tried one of two toric lenses in a daily wear modality.

Device: Senofilcon A Toric (AOfA); Device: Etafilcon A Toric (1DAMfA)

Habitual Correction with Spectacles (Neophytes)

OTHER

Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses tried one of two toric lenses in a daily wear modality.

Device: Senofilcon A Toric (AOfA); Device: Etafilcon A Toric (1DAMfA)

Interventions

Senofilcon A Toric (AOfA) DEVICE

Soft toric contact lenses for astigmatism

Contact lens drop-outs; Habitual Correction with Spectacles (Neophytes); Spherical contact lens users

Etafilcon A Toric (1DAMfA) DEVICE

Soft toric contact lenses for astigmatism

Contact lens drop-outs; Habitual Correction with Spectacles (Neophytes); Spherical contact lens users

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• One of the following:
• Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)
• Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day)
• Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses.
• Between 16 and 60 years of age.
• Have signed an informed consent form (documented by the investigator in the Case Report Form \[CRF\]).
• Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)
• Refractive astigmatism between -0.75D and -3.00D in both eyes.
• Have best corrected VA of 6/9 (20/30) or better in each eye.
• Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:
• No amblyopia.
• No evidence of lid abnormality or infection.
• No conjunctival abnormality or infection.
• No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularisation, infiltrates or abnormal opacities).
• No other active ocular disease.

You may not qualify if:

• Requires concurrent ocular medication.
• Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Corneal staining Grade 3 in more than two regions.
• Extended wear in the last 3 months.
• Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
• Abnormal lachrymal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Has diabetes.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• Pregnancy, lactating, or planning a pregnancy at the time of enrollment.
• Participation in any concurrent clinical trial or in last 60 days.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Visioncare Research Ltd.: collaborator

Study Sites (18)

Unknown Facility

Reading, Berkshire, United Kingdom

Location

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Marlow, Bucks, United Kingdom

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Broadstone, Dorset, United Kingdom

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Portchester, Hampshire, United Kingdom

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Southsea, Hampshire, United Kingdom

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St Albans, Herts, United Kingdom

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Shanklin, Isle Of Wight, United Kingdom

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Rawtenstall, Lancashire, United Kingdom

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Hendon, London, United Kingdom

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Pinner, Middlesex, United Kingdom

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Teddington, Middlesex, United Kingdom

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Uxbridge, Middlesex, United Kingdom

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Cardiff, South Glamorgan, United Kingdom

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Croydon, Surrey, United Kingdom

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Coventry, West Midlands, United Kingdom

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Birmingham, United Kingdom

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Bristol, United Kingdom

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Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Kathy Osborn, OD
• Organization: Johnson & Johnson Vision Care

KOsborn@its.jnj.com

1-904-443-1032

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 13, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: December 20, 2013

Record last verified: 2017-06

Locations

GB (18)