Comparative Clinical Evaluation of Soft Toric Lens Designs

NCT01552876 | Completed Results

• 1 other identifier: CR-4582
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Astigmatism; Myopia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Phase I: Time to Lens Settling

  5 minutes after lens insertion during Phase I

• Phase I: Number of Blinks Until Settled

  Baseline to 5 minutes during Phase I

Other Outcomes (1)

• Phase II: Absolute Rotation

  1-minute during Phase II

Study Arms (2)

etafilcon A / nelfilcon A / Filcon II 3

OTHER

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

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

nelfilcon A / etafilcon A / Filcon II 3

OTHER

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

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

Interventions

etafilcon A DEVICE

A daily wear contact lens

Also known as: 1-DAY ACUVUE MOIST for Astigmatism

etafilcon A / nelfilcon A / Filcon II 3; nelfilcon A / etafilcon A / Filcon II 3

nelfilcon A DEVICE

A daily wear contact lens

Also known as: Focus Dailies Toric All Day Comfort

etafilcon A / nelfilcon A / Filcon II 3; nelfilcon A / etafilcon A / Filcon II 3

Filcon II 3 DEVICE

a daily disposable

Also known as: Clariti(TM) 1 day Toric

etafilcon A / nelfilcon A / Filcon II 3; nelfilcon A / etafilcon A / Filcon II 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

Farnham, GU9 7EN, United Kingdom

Location

MeSH Terms

Conditions

Astigmatism; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Katherine Osborn OD, MS FAAO
• Organization: Johnson & Johnson Vision Care

kosborn@its.jnj.com

1 904 443-1032

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 13, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 19, 2018
• Results First Posted: August 15, 2014

Record last verified: 2015-05

Locations

GB (1)