Comparative Clinical Evaluation of Soft Toric Lens Designs

Not Applicable

Completed

• Conditions: Astigmatism; Myopia

• Registration Number: NCT01552876
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-10-30
• Results First Submitted QC: 2014-08-14
• Results First Posted: 2014-08-15
• Status Verified: 2015-05
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Phase I: Absolute Lens Rotation	3 min after lens insertion during Phase I	Lens orientation position as assessed on a scale of 0-180 on both eyes.

Secondary Outcome Measures

Name	Time	Method
Phase I: Time to Lens Settling	5 minutes after lens insertion during Phase I	With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.
Phase I: Number of Blinks Until Settled	Baseline to 5 minutes during Phase I	Number of blinks for the right eye was counted until lens settling using headcam video.