Daily Disposable Contact Lens Tear Film Study
|ClinicalTrials.gov Identifier: NCT01473160|
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : January 16, 2013
Last Update Posted : April 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: delefilcon A contact lens Device: narafilcon A contact lens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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
- Number of Participants With Corrected Visual Acuity of 0.0 or Better [ Time Frame: Up to 16 hours after lens insertion ]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 ]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 ]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 ]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.
- Subjective Comfort [ Time Frame: Up to 16 hours after lens insertion ]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 ]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 ]Lens fit was assessed by the investigator with a biomicroscope (slit lamp).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473160
|Birmingham, United Kingdom, B4 7ET|