Trial Outcomes & Findings for Daily Disposable Contact Lens Tear Film Study (NCT NCT01473160)
NCT ID: NCT01473160
Last Updated: 2013-04-17
Results Overview
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.
COMPLETED
NA
9 participants
Up to 16 hours after lens insertion
2013-04-17
Participant Flow
Participants were recruited from one study center in the UK.
Participant milestones
| Measure |
Overall Study
All enrolled participants
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daily Disposable Contact Lens Tear Film Study
Baseline characteristics by cohort
| Measure |
Overall Study
n=9 Participants
All enrolled participants
|
|---|---|
|
Age Continuous
|
31 years
STANDARD_DEVIATION 7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 16 hours after lens insertionPopulation: All enrolled participants
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.
Outcome measures
| Measure |
Delefilcon A
n=9 Participants
Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
|
Narafilcon A
n=9 Participants
Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
|
|---|---|---|
|
Number of Participants With Corrected Visual Acuity of 0.0 or Better
8 hours after lens insertion
|
9 participants
0.079
|
9 participants
0.089
|
|
Number of Participants With Corrected Visual Acuity of 0.0 or Better
12 hours after lens insertion
|
9 participants
0.058
|
9 participants
0.078
|
|
Number of Participants With Corrected Visual Acuity of 0.0 or Better
16 hours after lens insertion
|
9 participants
0.079
|
9 participants
0.063
|
PRIMARY outcome
Timeframe: Up to 16 hours after lens insertionPopulation: All enrolled participants
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.
Outcome measures
| Measure |
Delefilcon A
n=9 Participants
Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
|
Narafilcon A
n=9 Participants
Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
|
|---|---|---|
|
Pre-Lens Noninvasive Tear Break-Up Time
8 hours after lens insertion
|
12.7 seconds
Standard Deviation 5.3
|
11.3 seconds
Standard Deviation 3.5
|
|
Pre-Lens Noninvasive Tear Break-Up Time
12 hours after lens insertion
|
12.2 seconds
Standard Deviation 5.9
|
13.8 seconds
Standard Deviation 5.4
|
|
Pre-Lens Noninvasive Tear Break-Up Time
16 hours after lens insertion
|
10.5 seconds
Standard Deviation 4.5
|
10.1 seconds
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Up to 16 hours after lens insertionPopulation: All enrolled participants
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.
Outcome measures
| Measure |
Delefilcon A
n=9 Participants
Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
|
Narafilcon A
n=9 Participants
Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
|
|---|---|---|
|
Average Tear Meniscus Height
8 hours after lens insertion
|
28.0 pixels
Standard Deviation 6.9
|
26.7 pixels
Standard Deviation 8.2
|
|
Average Tear Meniscus Height
12 hours after lens insertion
|
26.0 pixels
Standard Deviation 5.2
|
24.0 pixels
Standard Deviation 7.7
|
|
Average Tear Meniscus Height
16 hours after lens insertion
|
28.7 pixels
Standard Deviation 11.1
|
27.1 pixels
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: Up to 16 hours after lens insertionPopulation: All enrolled participants
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.
Outcome measures
| Measure |
Delefilcon A
n=9 Participants
Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
|
Narafilcon A
n=9 Participants
Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
|
|---|---|---|
|
Average Ocular Surface Temperature
8 hours after lens insertion
|
35.6 Degrees Celsius
Standard Deviation 0.8
|
35.3 Degrees Celsius
Standard Deviation 0.8
|
|
Average Ocular Surface Temperature
12 hours after lens insertion
|
35.2 Degrees Celsius
Standard Deviation 0.8
|
35.2 Degrees Celsius
Standard Deviation 0.9
|
|
Average Ocular Surface Temperature
16 hours after lens insertion
|
35.5 Degrees Celsius
Standard Deviation 0.8
|
35.3 Degrees Celsius
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Up to 16 hours after lens insertionPopulation: All enrolled participants
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?"
Outcome measures
| Measure |
Delefilcon A
n=9 Participants
Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
|
Narafilcon A
n=9 Participants
Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
|
|---|---|---|
|
Subjective Comfort
8 hours after lens insertion
|
9.1 Units on a scale
Standard Deviation 0.8
|
6.8 Units on a scale
Standard Deviation 2.3
|
|
Subjective Comfort
12 hours after lens insertion
|
9.0 Units on a scale
Standard Deviation 0.9
|
6.7 Units on a scale
Standard Deviation 2.1
|
|
Subjective Comfort
16 hours after lens insertion
|
9.1 Units on a scale
Standard Deviation 0.8
|
6.3 Units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Up to 16 hours after lens insertionPopulation: All enrolled participants
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?"
Outcome measures
| Measure |
Delefilcon A
n=9 Participants
Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
|
Narafilcon A
n=9 Participants
Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
|
|---|---|---|
|
Subjective Vision
8 hours after lens insertion
|
9.0 Units on a scale
Standard Deviation 1.3
|
7.8 Units on a scale
Standard Deviation 1.9
|
|
Subjective Vision
12 hours after lens insertion
|
8.7 Units on a scale
Standard Deviation 1.4
|
7.8 Units on a scale
Standard Deviation 1.6
|
|
Subjective Vision
16 hours after lens insertion
|
8.7 Units on a scale
Standard Deviation 1.3
|
8.0 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Up to 16 hours after lens insertionPopulation: All enrolled participants
Lens fit was assessed by the investigator with a biomicroscope (slit lamp).
Outcome measures
| Measure |
Delefilcon A
n=9 Participants
Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
|
Narafilcon A
n=9 Participants
Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
|
|---|---|---|
|
Number of Participants With Adequate Lens Fit
8 hours after lens insertion
|
9 Participants
|
9 Participants
|
|
Number of Participants With Adequate Lens Fit
12 hours after lens insertion
|
9 Participants
|
9 Participants
|
|
Number of Participants With Adequate Lens Fit
16 hours after lens insertion
|
9 Participants
|
9 Participants
|
Adverse Events
Delefilcon A
Narafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place