Clinical Validation of the New Print on Focus DAILIES Toric

NCT01097863 | Completed Results

• 1 other identifier: P-346-C-010
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to validate the improvements to the inversion indicator.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.

  As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.

  1 week

Study Arms (3)

nelfilcon A, modified inversion indicator

EXPERIMENTAL

Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week

Device: nelfilcon A contact lens, modified inversion indicator

nelfilcon A, no inversion indicator

EXPERIMENTAL

Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week

Device: nelfilcon A contact lens, no inversion indicator

nelfilcon A, inversion indicator

ACTIVE COMPARATOR

Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.

Device: nelfilcon A contact lens, inversion indicator

Interventions

nelfilcon A contact lens, modified inversion indicator DEVICE

Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator

nelfilcon A, modified inversion indicator

nelfilcon A contact lens, no inversion indicator DEVICE

Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator

nelfilcon A, no inversion indicator

nelfilcon A contact lens, inversion indicator DEVICE

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator

Also known as: Focus DAILIES Toric

nelfilcon A, inversion indicator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
• Willing and able to wear study lenses in both eyes in the available parameters.
• Light-eyed subjects.
• Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
• Optimal or acceptable fit in each eye at time of dispensing.
• Willing to wear the study lenses at least 8 hours a day, 5 days a week.

You may not qualify if:

• Eye injury or surgery within twelve weeks prior to enrollment for this trial.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in an ophthalmic clinical trial.
• Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• RGP contact lens wearer.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
• Organization: CIBA VISION

priya.janakiraman@cibavision.com

1-800-241-7629

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 2, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 10, 2012
• Results First Posted: June 27, 2011

Record last verified: 2012-01