Comparative Clinical Evaluation of Soft Toric Lens Designs

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: nelfilcon A; Device: Filcon II 3; Device: etafilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01552876

CR-4582

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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42 participants in 2 patient groups

etafilcon A / nelfilcon A / Filcon II 3

Other group

Description:

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

Treatment:

Device: etafilcon A

Device: Filcon II 3

Device: nelfilcon A

nelfilcon A / etafilcon A / Filcon II 3

Other group

Description:

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

Treatment:

Device: etafilcon A

Device: Filcon II 3

Device: nelfilcon A