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Trial Outcomes & Findings for Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric (NCT NCT02289742)

NCT ID: NCT02289742

Last Updated: 2016-07-26

Results Overview

A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

Hour 12, each product

Results posted on

2016-07-26

Participant Flow

Subjects were recruited from 1 study center located in Germany.

Of the 48 enrolled subjects, 3 were discontinued as screen failures prior to randomization. This reporting group includes all randomized subjects (45).

Participant milestones

Participant milestones
Measure
Presbyopes MF/Sphere
Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
Presbyopes Sphere/MF
Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
Astigmats Toric/Sphere
Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
Astigmats Sphere/Toric
Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
First Wear Period
STARTED
11
12
12
10
First Wear Period
Treated
11
11
12
9
First Wear Period
COMPLETED
11
11
11
9
First Wear Period
NOT COMPLETED
0
1
1
1
Second Wear Period
STARTED
11
11
11
9
Second Wear Period
COMPLETED
11
11
11
9
Second Wear Period
NOT COMPLETED
0
0
0
0
Third Wear Period
STARTED
11
11
11
9
Third Wear Period
COMPLETED
11
10
11
8
Third Wear Period
NOT COMPLETED
0
1
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Presbyopes MF/Sphere
Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
Presbyopes Sphere/MF
Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
Astigmats Toric/Sphere
Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
Astigmats Sphere/Toric
Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
First Wear Period
Adverse event prior to treatment
0
1
0
0
First Wear Period
Adverse Event
0
0
1
0
First Wear Period
Other prior to treatment
0
0
0
1
Third Wear Period
Adverse Event
0
1
0
0
Third Wear Period
Reason not given
0
0
0
1

Baseline Characteristics

Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Presbyopes
n=22 Participants
Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
Astigmats
n=21 Participants
Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
Total
n=43 Participants
Total of all reporting groups
Age, Continuous
51.7 years
STANDARD_DEVIATION 8.1 • n=93 Participants
25.8 years
STANDARD_DEVIATION 4.5 • n=4 Participants
39.0 years
STANDARD_DEVIATION 14.6 • n=27 Participants
Sex: Female, Male
Female
16 Participants
n=93 Participants
16 Participants
n=4 Participants
32 Participants
n=27 Participants
Sex: Female, Male
Male
6 Participants
n=93 Participants
5 Participants
n=4 Participants
11 Participants
n=27 Participants
Region of Enrollment
Germany
22 participants
n=93 Participants
21 participants
n=4 Participants
43 participants
n=27 Participants

PRIMARY outcome

Timeframe: Hour 12, each product

Population: This analysis population includes all randomized and exposed subjects with data at visit.

A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.

Outcome measures

Outcome measures
Measure
Presbyopes / Multifocal
n=22 Participants
Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
Presbyopes / Sphere
n=22 Participants
Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
Astigmats / Toric
n=21 Participants
Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design)
Astigmats / Sphere
n=20 Participants
Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
55.8 percentage of subjects
47.2 percentage of subjects
46.5 percentage of subjects
49.5 percentage of subjects

SECONDARY outcome

Timeframe: Hour 8, each product

Population: This analysis population includes all randomized and exposed subjects with data at visit.

A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.

Outcome measures

Outcome measures
Measure
Presbyopes / Multifocal
n=22 Participants
Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
Presbyopes / Sphere
n=22 Participants
Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
Astigmats / Toric
n=21 Participants
Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design)
Astigmats / Sphere
n=20 Participants
Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear
60.8 percentage of subjects
46.3 percentage of subjects
34.3 percentage of subjects
33.3 percentage of subjects

Adverse Events

Pre-treatment

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

Presbyopes / Multifocal

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

Presbyopes / Sphere First Exposure

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

Presbyopes / Sphere Second Exposure

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

Astigmats / Toric

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

Astigmats / Sphere First Exposure

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

Astigmats / Sphere Second Exposure

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

Global Medical Affairs, Brand Lead - Vision Care

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