Clinical Validation of the New Print on Focus DAILIES Toric

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097863
• Other study ID #: P-346-C-010
• Status: Completed
• Phase: N/A
• First received: March 31, 2010
• Last updated: June 26, 2012
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• nelfilcon A contact lens, modified inversion indicator
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
• nelfilcon A contact lens, no inversion indicator
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
• nelfilcon A contact lens, inversion indicator
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No