Comparative Clinical Evaluation of Soft Toric Lens Designs

Myopia Clinical Trial

Official title:

Comparative Clinical Evaluation of Soft Toric Lens Designs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552876
• Other study ID #: CR-4582
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• etafilcon A
A daily wear contact lens
• nelfilcon A
A daily wear contact lens
• Filcon II 3
a daily disposable

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Phase II: Absolute Rotation	Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.	1-minute during Phase II
Primary	Phase I: Absolute Lens Rotation	At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.	At 1-min after lens insertion during Phase I
Primary	Phase I: Absolute Lens Rotation	Lens orientation position as assessed on a scale of 0-180 on both eyes.	3 min after lens insertion during Phase I
Secondary	Phase I: Time to Lens Settling	With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.	5 minutes after lens insertion during Phase I
Secondary	Phase I: Number of Blinks Until Settled	Number of blinks for the right eye was counted until lens settling using headcam video.	Baseline to 5 minutes during Phase I