Daily Disposable Contact Lens Tear Film Study

NCT01473160 | Completed Results

• 1 other identifier: P-347-C-014v2
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Corrected Visual Acuity of 0.0 or Better

  Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.

  Up to 16 hours after lens insertion

• Pre-Lens Noninvasive Tear Break-Up Time

  The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.

  Up to 16 hours after lens insertion

• Average Tear Meniscus Height

  The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.

  Up to 16 hours after lens insertion

• Average Ocular Surface Temperature

  Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.

  Up to 16 hours after lens insertion

Secondary Outcomes (3)

• Subjective Comfort

  Up to 16 hours after lens insertion

• Subjective Vision

  Up to 16 hours after lens insertion

• Number of Participants With Adequate Lens Fit

  Up to 16 hours after lens insertion

Study Arms (2)

delefilcon A

EXPERIMENTAL

Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).

Device: delefilcon A contact lens

narafilcon A

ACTIVE COMPARATOR

Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).

Device: narafilcon A contact lens

Interventions

delefilcon A contact lens DEVICE

CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear

Also known as: DAILIES TOTAL1

delefilcon A

narafilcon A contact lens DEVICE

Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.

Also known as: 1-DAY ACUVUE TruEye

narafilcon A

Eligibility Criteria

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

You may qualify if:

• Be of legal age of consent and sign Informed Consent document.
• Willing and able to wear spherical contact lenses for 16 hours.
• Willing and able to wear spherical contact lenses within the available range of powers.
• Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.

You may not qualify if:

• Anterior segment infection, inflammation, or abnormality.
• Any use of systemic medications for which contact lens wear could be contraindicated.
• History of refractive surgery or irregular cornea.
• Currently enrolled in any clinical trial.
• Eye injury within twelve weeks prior to enrollment.

Sponsors & Collaborators

• CIBA VISION: lead
• Aston University: collaborator

Study Sites (1)

Aston University

Birmingham, B4 7ET, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Pilot study. Small number of participants analyzed.

Results Point of Contact

• Title: Joachim Nick, Dipl. Ing.
• Organization: Alcon Research, Ltd.

joachim.nick@cibavision.com

+49 6022 240 520

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 17, 2013
• Results First Posted: January 16, 2013

Record last verified: 2013-01

Locations

GB (1)