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Trial Outcomes & Findings for Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses (NCT NCT01839318)

NCT ID: NCT01839318

Last Updated: 2014-06-20

Results Overview

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 contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Hour 8

Results posted on

2014-06-20

Participant Flow

Participants were recruited from 1 study center located in Germany.

Of the 30 enrolled, 2 participants discontinued before product was dispensed. This reporting group includes all participants exposed to the study product (28). In this 3-treatment, 6-sequence crossover study, each participant received all 3 products in randomized order and used 1 product at a time for a duration of 12 hours.

Participant milestones

Participant milestones
Measure
Sequence 1
Omafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
Sequence 2
Omafilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
Sequence 3
Nelfilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
Sequence 4
Nelfilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
Sequence 5
Etafilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
Sequence 6
Etafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
Period 1, First Day of Wear
STARTED
4
4
5
6
7
2
Period 1, First Day of Wear
COMPLETED
4
4
5
6
7
2
Period 1, First Day of Wear
NOT COMPLETED
0
0
0
0
0
0
Period 2, Second Day of Wear
STARTED
4
4
5
6
7
2
Period 2, Second Day of Wear
COMPLETED
4
4
5
6
7
2
Period 2, Second Day of Wear
NOT COMPLETED
0
0
0
0
0
0
Period 3, Third Day of Wear
STARTED
4
4
5
6
7
2
Period 3, Third Day of Wear
COMPLETED
4
4
5
6
7
2
Period 3, Third Day of Wear
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=28 Participants
Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment.
Age, Continuous
24.96 years
STANDARD_DEVIATION 3.54 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Hour 8

Population: This analysis population includes all participants exposed to the study product with reportable values.

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 contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.

Outcome measures

Outcome measures
Measure
DAILIES AquaComfort Plus
n=27 Participants
Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
1-DAY ACUVUE MOIST
n=26 Participants
Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
Proclear 1 Day
n=27 Participants
Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours
5.28 seconds
Standard Deviation 5.71
3.46 seconds
Standard Deviation 4.52
4.93 seconds
Standard Deviation 6.34

SECONDARY outcome

Timeframe: Hour 8

Population: This analysis population includes all participants exposed to the study product with reportable values.

The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.

Outcome measures

Outcome measures
Measure
DAILIES AquaComfort Plus
n=27 Participants
Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
1-DAY ACUVUE MOIST
n=26 Participants
Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
Proclear 1 Day
n=27 Participants
Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
Total Wettability Score
5 seconds post blink
0.74 units on a scale
Standard Deviation 0.93
0.83 units on a scale
Standard Deviation 0.87
0.84 units on a scale
Standard Deviation 0.96
Total Wettability Score
10 seconds post blink
1.25 units on a scale
Standard Deviation 1.15
1.20 units on a scale
Standard Deviation 1.14
1.42 units on a scale
Standard Deviation 1.2
Total Wettability Score
15 seconds post blink
1.58 units on a scale
Standard Deviation 1.2
1.54 units on a scale
Standard Deviation 1.21
1.66 units on a scale
Standard Deviation 1.19
Total Wettability Score
20 seconds post blink
1.69 units on a scale
Standard Deviation 1.21
1.78 units on a scale
Standard Deviation 1.22
1.89 units on a scale
Standard Deviation 1.18
Total Wettability Score
25 seconds post blink
1.79 units on a scale
Standard Deviation 1.18
1.94 units on a scale
Standard Deviation 1.19
2.03 units on a scale
Standard Deviation 1.17

Adverse Events

DAILIES AquaComfort Plus

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

1-DAY ACUVUE MOIST

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Proclear 1 Day

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessie Lemp, GMA Brand Lead

Alcon Research, Ltd.

Phone: 1-888-451-3937

Results disclosure agreements

  • Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
  • Publication restrictions are in place

Restriction type: OTHER