Daily Disposable Contact Lens Tear Film Study - Full Text View

Purpose

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.

Condition	Intervention
Myopia	Device: delefilcon A contact lens Device: narafilcon A contact lens

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Number of Participants With Corrected Visual Acuity of 0.0 or Better [ Time Frame: Up to 16 hours after lens insertion ] [ Designated as safety issue: No ]
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.
Pre-Lens Noninvasive Tear Break-Up Time [ Time Frame: Up to 16 hours after lens insertion ] [ Designated as safety issue: No ]
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.
Average Tear Meniscus Height [ Time Frame: Up to 16 hours after lens insertion ] [ Designated as safety issue: No ]
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.
Average Ocular Surface Temperature [ Time Frame: Up to 16 hours after lens insertion ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Subjective Comfort [ Time Frame: Up to 16 hours after lens insertion ] [ Designated as safety issue: No ]
Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"
Subjective Vision [ Time Frame: Up to 16 hours after lens insertion ] [ Designated as safety issue: No ]
Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, "What is the quality of your vision with the lens at present?"
Number of Participants With Adequate Lens Fit [ Time Frame: Up to 16 hours after lens insertion ] [ Designated as safety issue: No ]
Lens fit was assessed by the investigator with a biomicroscope (slit lamp).

Enrollment:	9
Study Start Date:	November 2011
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: delefilcon A 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 CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear Other Name: DAILIES TOTAL1
Active Comparator: narafilcon A 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 Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear. Other Name: 1-DAY ACUVUE TruEye

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

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.
Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473160

Locations

United Kingdom
Aston University
Birmingham, United Kingdom, B4 7ET

Sponsors and Collaborators

CIBA VISION

Aston University

More Information

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01473160 History of Changes
Other Study ID Numbers:	P-347-C-014v2
Study First Received:	November 14, 2011
Results First Received:	November 19, 2012
Last Updated:	April 16, 2013
Health Authority:	United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013