Prospective Study of an Investigational Toric Soft Contact Lens

NCT01461811 | Completed Results

• 1 other identifier: C-11-035 (P-415-C-003)
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.

Conditions

Myopia; Astigmatism; Refractive Error

Keywords

toric; contact lenses; daily disposable contact lenses; astigmatism; soft contact lenses; contact lens comfort

Outcome Measures

Primary Outcomes (1)

• Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)

  Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.

  Up to Month 3

Secondary Outcomes (11)

• Subjective Rating of Insertion Comfort

  Up to Month 3

• Subjective Rating of End of Day Comfort

  Up to Month 3

• Subjective Rating of Overall Comfort

  Up to Month 3

• Subjective Rating of End of Day Dryness

  Up to Month 3

• Subjective Rating of Overall Vision

  Up to Month 3

Study Arms (2)

DAILIES® AquaComfort Plus® Toric

EXPERIMENTAL

Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months

Device: Nelfilcon A toric contact lenses (with comfort additives)

Focus® DAILIES® Toric

ACTIVE COMPARATOR

Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months

Device: Nelfilcon A toric contact lenses

Interventions

Nelfilcon A toric contact lenses (with comfort additives) DEVICE

DAILIES® AquaComfort Plus® Toric

Nelfilcon A toric contact lenses DEVICE

Also known as: Focus® DAILIES® Toric

Focus® DAILIES® Toric

Eligibility Criteria

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

You may qualify if:

• Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
• Normal eyes not using any ocular medications that would contraindicate lens wear.
• Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
• Spectacle cylinder prescription between 0.50 and 2.00 diopters.
• Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.

You may not qualify if:

• Anterior segment infection, inflammation, or abnormality.
• Any active anterior segment or systemic disease that would contraindicate contact lens wear.
• Use of systemic medications that would contraindicate lens wear.
• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
• History of herpetic keratitis.
• History of refractive surgery or irregular cornea.
• History of pathologically dry eye.
• Corneal vascularization greater than 1 mm of penetration.
• Eye injury within twelve weeks immediately prior to enrollment in this trial.
• Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia; Astigmatism; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Mary Fahmy, OD, Clinical Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Mary Fahmy, OD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 28, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 17, 2013
• Results First Posted: October 17, 2013

Record last verified: 2013-08