Trial Outcomes & Findings for On-Eye Evaluation of Contact Lens Axis Location (NCT NCT02100410)

Last Updated: 2014-05-16

Results Overview

Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Day 1

Results posted on

2014-05-16

Participant Flow

Participants were recruited from 1 study center located in the US.

Of the 50 enrolled, 1 participant was exited as a screen failure prior to randomization and exposure to the study product. This reporting group includes all randomized participants (49).

Participant milestones

Participant milestones
Measure	Sequence 1 T1 and T2; T3 and T4; T5 and T6	Sequence 2 T1 and T2; T5 and T6; T3 and T4	Sequence 3 T3 and T4; T1 and T2; T5 and T6	Sequence 4 T3 and T4; T5 and T6; T1 and T2	Sequence 5 T5 and T6; T1 and T2; T3 and T4	Sequence 6 T5 and T6; T3 and T4; T1 and T2
Exposure Pair 1, 30 Minutes STARTED	8	8	8	8	8	9
Exposure Pair 1, 30 Minutes COMPLETED	8	8	8	8	8	9
Exposure Pair 1, 30 Minutes NOT COMPLETED	0	0	0	0	0	0
Exposure Pair 2, 30 Minutes STARTED	8	8	8	8	8	9
Exposure Pair 2, 30 Minutes COMPLETED	8	8	8	8	8	9
Exposure Pair 2, 30 Minutes NOT COMPLETED	0	0	0	0	0	0
Exposure Pair 3, 30 Minutes STARTED	8	8	8	8	8	9
Exposure Pair 3, 30 Minutes COMPLETED	8	8	8	8	8	9
Exposure Pair 3, 30 Minutes NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

On-Eye Evaluation of Contact Lens Axis Location

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=49 Participants All treatment sequences
Age, Customized 18 - 68 Years	45.4 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.

Outcome measures

Outcome measures
Measure	TEST1 n=49 Participants Iteration 2-87-1 with embossed mark	TEST3 n=49 Participants Iteration 2-87-2 with embossed mark	TEST5 n=49 Participants Iteration 2-87-3 with embossed mark	TEST4 Iteration 2-87-2 without embossed mark	TEST5 Iteration 2-87-3 with embossed mark	TEST6 Iteration 2-87-3 without embossed mark
Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear	24.5 percentage of lenses	46.9 percentage of lenses	36.7 percentage of lenses	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.

Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.

Outcome measures

Outcome measures
Measure	TEST1 n=49 Participants Iteration 2-87-1 with embossed mark	TEST3 n=49 Participants Iteration 2-87-2 with embossed mark	TEST5 n=49 Participants Iteration 2-87-3 with embossed mark	TEST4 n=49 Participants Iteration 2-87-2 without embossed mark	TEST5 n=49 Participants Iteration 2-87-3 with embossed mark	TEST6 n=49 Participants Iteration 2-87-3 without embossed mark
Lens Awareness	0.6 units on a scale Standard Deviation 0.8	0.2 units on a scale Standard Deviation 0.5	0.4 units on a scale Standard Deviation 0.7	0.2 units on a scale Standard Deviation 0.4	1.0 units on a scale Standard Deviation 1.1	0.6 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Day 1

Population: This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.

Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).

Outcome measures

Outcome measures
Measure	TEST1 n=49 Participants Iteration 2-87-1 with embossed mark	TEST3 n=49 Participants Iteration 2-87-2 with embossed mark	TEST5 n=49 Participants Iteration 2-87-3 with embossed mark	TEST4 Iteration 2-87-2 without embossed mark	TEST5 Iteration 2-87-3 with embossed mark	TEST6 Iteration 2-87-3 without embossed mark
Handling on Removal	8.0 units on a scale Standard Deviation 2.4	7.8 units on a scale Standard Deviation 2.6	8.9 units on a scale Standard Deviation 1.8	—	—	—

Adverse Events

TEST (1,3,5)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TEST (2,4,6)

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

Joachim Nick, Dipl.-Ing. (FH), Clinical Lead

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place