Comparative Clinical Evaluation of Soft Toric Lens Designs

NCT ID: NCT01552876

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-04-30

Brief Summary

This study is evaluating the initial fit of toric contact lenses.

Conditions

Astigmatism; Myopia

Study Design

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

Study Groups

etafilcon A / nelfilcon A / Filcon II 3

etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third.

Group Type: OTHER

etafilcon A

Intervention Type: DEVICE

A daily wear contact lens

nelfilcon A

Intervention Type: DEVICE

A daily wear contact lens

Filcon II 3

Intervention Type: DEVICE

a daily disposable

nelfilcon A / etafilcon A / Filcon II 3

nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third.

Group Type: OTHER

etafilcon A

Intervention Type: DEVICE

A daily wear contact lens

nelfilcon A

Intervention Type: DEVICE

A daily wear contact lens

Filcon II 3

Intervention Type: DEVICE

a daily disposable

Interventions

etafilcon A

A daily wear contact lens

Intervention Type: DEVICE

nelfilcon A

A daily wear contact lens

Intervention Type: DEVICE

Filcon II 3

a daily disposable

Intervention Type: DEVICE

Other Intervention Names

1-DAY ACUVUE MOIST for Astigmatism; Focus Dailies Toric All Day Comfort; Clariti(TM) 1 day Toric

Eligibility Criteria

Inclusion Criteria

• Be greater than or equal to 18 years old.
• Read, understand, and sign written Statement of Informed Consent.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
• Require a visual correction in both eyes (monovision allowed but no monofit).
• Have a spherical contact lens requirement in the range -0.50D to -6.00D.
• Have astigmatism of between -0.50 and -2.00DC in both eyes.
• Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction.
• Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery

Exclusion Criteria

• Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months.
• Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
• Extended lens wear in last 3 months.
• Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
• Any systemic disease affecting ocular health.
• Abnormal lacrimal secretions.
• Keratoconus or other corneal irregularity.
• Pregnancy, lactating or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial.
• Any previous anterior ocular surgery.
• Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis).
• Subjects who are known to have an immunosuppressive disease (e.g., HIV positive).
• Subjects who are known to have diabetes.
• Employees or family members of the Research site, Principal Investigator or study team.

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

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Farnham, , United Kingdom

Countries

United Kingdom

Other Identifiers

CR-4582

Identifier Type: -

Identifier Source: org_study_id