Daily Disposable Contact Lens Tear Film Study

This study has been completed.
Sponsor:
Collaborator:
Aston University
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01473160
First received: November 14, 2011
Last updated: April 16, 2013
Last verified: January 2013

November 14, 2011
April 16, 2013
November 2011
December 2011   (final data collection date for primary outcome measure)
  • 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.
  • Visual Acuity [ Time Frame: 16 hours after lens insertion ] [ Designated as safety issue: No ]
    Visual acuity will be assessed with optotypes.
  • Pre-Lens Noninvasive Tear Break-Up Time [ Time Frame: 16 hours after lens insertion ] [ Designated as safety issue: No ]
    Pre-Lens Noninvasive Tear Break-Up Time will be measured by the investigator with a CA-1000 topographer (Topcon, Newbury, UK).
  • Tear Prism Height [ Time Frame: 16 hours after lens insertion ] [ Designated as safety issue: No ]
    Tear Prism Height will be measured by the investigator with digital slit lamp images.
  • Ocular Surface Temperature [ Time Frame: 16 hours after lens insertion ] [ Designated as safety issue: No ]
    Ocular Surface Temperature will be recorded by the investigator with a dynamic, non-contact, infrared thermography camera.
Complete list of historical versions of study NCT01473160 on ClinicalTrials.gov Archive Site
  • 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).
  • Comfort [ Time Frame: 16 hours after lens wear ] [ Designated as safety issue: No ]
    Comfort will be assessed and recorded by the participant on a questionnaire.
  • Vision [ Time Frame: 16 hours after lens insertion ] [ Designated as safety issue: No ]
    Vision will be assessed and recorded by the participant on a questionnaire.
  • Lens Fit [ Time Frame: 16 hours after lens insertion ] [ Designated as safety issue: No ]
    Lens fit will be assessed by the investigator with a biomicroscope (slit lamp).
Not Provided
Not Provided
 
Daily Disposable Contact Lens Tear Film Study
DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Myopia
  • Device: delefilcon A contact lens
    CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear
    Other Name: DAILIES TOTAL1
  • Device: narafilcon A contact lens
    Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.
    Other Name: 1-DAY ACUVUE TruEye
  • 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).
    Intervention: Device: delefilcon A contact lens
  • 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).
    Intervention: Device: narafilcon A contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01473160
P-347-C-014v2
No
Alcon Research ( CIBA VISION )
CIBA VISION
Aston University
Not Provided
Alcon Research
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP