On-Eye Evaluation of Contact Lens Axis Location

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02100410
• Collaborator: (none)
• Enrollment: 50
• Arms: 3

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism; Refractive Error	Device: Delefilcon A toric contact lens T1; Device: Delefilcon A toric contact lens T2; Device: Delefilcon A toric contact lens T3; Device: Delefilcon A toric contact lens T4; Device: Delefilcon A toric contact lens T5; Device: Delefilcon A toric contact lens T6	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iteration 2-87-1 Delefilcon A toric contact lenses T1 and T2 worn contralaterally (1 in each eye) for approximately 30 minutes	Device: Delefilcon A toric contact lens T1; Iteration 2-87-1 with embossed mark; Device: Delefilcon A toric contact lens T2; Iteration 2-87-1 without embossed mark
Experimental: Iteration 2-87-2 Delefilcon A toric contact lenses T3 and T4 worn contralaterally (1 in each eye) for approximately 30 minutes	Device: Delefilcon A toric contact lens T3; Iteration 2-87-2 with embossed mark; Device: Delefilcon A toric contact lens T4; Iteration 2-87-2 without embossed mark
Experimental: Iteration 2-87-3 Delefilcon A toric contact lenses T5 and T6 worn contralaterally (1 in each eye) for approximately 30 minutes	Device: Delefilcon A toric contact lens T5; Iteration 2-87-3 with embossed mark; Device: Delefilcon A toric contact lens T6; Iteration 2-87-3 without embossed mark

Outcome Measures

Primary Outcome Measures

1. Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear [Day 1]

   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).

Secondary Outcome Measures

1. Lens Awareness [Day 1]

   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.

2. Handling on Removal [Day 1]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sign written Informed Consent.

• Best corrected distance visual acuity greater than or equal to 20/25 in each eye.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study.

• Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.

• History of herpetic keratitis.

• Slit-lamp findings at baseline as specified in the protocol.

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear.

• Clinically significant dry eye not responding to treatment.

• History of refractive surgery.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Joachim Nick, Dipl. Ing., Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02100410
• Other Study ID Numbers: C-12-061
• First Posted: Apr 1, 2014
• Last Update Posted: May 16, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Alcon Research: Contact Lens; Toric
• Additional relevant MeSH terms: Astigmatism; Refractive Errors

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 study center located in the US.
Pre-assignment Detail	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).

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6
Arm/Group Description	T1 and T2; T3 and T4; T5 and T6	T1 and T2; T5 and T6; T3 and T4	T3 and T4; T1 and T2; T5 and T6	T3 and T4; T5 and T6; T1 and T2	T5 and T6; T1 and T2; T3 and T4	T5 and T6; T3 and T4; T1 and T2
Period Title: Exposure Pair 1, 30 Minutes
STARTED	8	8	8	8	8	9
COMPLETED	8	8	8	8	8	9
NOT COMPLETED	0	0	0	0	0	0
Period Title: Exposure Pair 1, 30 Minutes
STARTED	8	8	8	8	8	9
COMPLETED	8	8	8	8	8	9
NOT COMPLETED	0	0	0	0	0	0
Period Title: Exposure Pair 1, 30 Minutes
STARTED	8	8	8	8	8	9
COMPLETED	8	8	8	8	8	9
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	All treatment sequences
Overall Participants	49
Age, Customized (years) [Mean (Standard Deviation) ]
18 - 68 Years	45.4 (13.6)
Sex: Female, Male (Count of Participants)
Female	29 59.2%
Male	20 40.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TEST1	TEST3	TEST5
Arm/Group Description	Iteration 2-87-1 with embossed mark	Iteration 2-87-2 with embossed mark	Iteration 2-87-3 with embossed mark
Measure Participants	49	49	49
Number [percentage of lenses]	24.5	46.9	36.7

2. Secondary Outcome

Title	Lens Awareness
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TEST1	TEST2	TEST3	TEST4	TEST5	TEST6
Arm/Group Description	Iteration 2-87-1 with embossed mark	Iteration 2-87-1 without embossed mark	Iteration 2-87-2 with embossed mark	Iteration 2-87-2 without embossed mark	Iteration 2-87-3 with embossed mark	Iteration 2-87-3 without embossed mark
Measure Participants	49	49	49	49	49	49
Mean (Standard Deviation) [units on a scale]	0.6 (0.8)	0.2 (0.5)	0.4 (0.7)	0.2 (0.4)	1.0 (1.1)	0.6 (0.7)

3. Secondary Outcome

Title	Handling on Removal
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TEST1	TEST3	TEST5
Arm/Group Description	Iteration 2-87-1 with embossed mark	Iteration 2-87-2 with embossed mark	Iteration 2-87-3 with embossed mark
Measure Participants	49	49	49
Mean (Standard Deviation) [units on a scale]	8.0 (2.4)	7.8 (2.6)	8.9 (1.8)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (18 days). This analysis group includes all participants/eyes exposed to the investigational products (embossed or non-embossed lenses).
Adverse Event Reporting Description	AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device.
Arm/Group Title	TEST (1,3,5)		TEST (2,4,6)
Arm/Group Description	Delefilcon A toric contact lenses with embossed mark, 3 different iterations, crossover all on the same eye		Delefilcon A toric contact lenses without embossed mark, 3 different iterations, crossover all on the same eye
All Cause Mortality
	TEST (1,3,5)		TEST (2,4,6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	TEST (1,3,5)		TEST (2,4,6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	TEST (1,3,5)		TEST (2,4,6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.