Trial Outcomes & Findings for Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees (NCT NCT00583908)

Results Overview

Degree of lens rotation on the eye with the head tilted.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

after fit of each of the four lens insertions

Results posted on

2015-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.	Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
Period 1 - First Intervention STARTED	1	2	1	1	2	1	1	1	1	1	1	1
Period 1 - First Intervention COMPLETED	1	2	1	1	2	1	1	1	1	1	1	1
Period 1 - First Intervention NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Period 2 - Second Intervention STARTED	1	2	1	1	2	1	1	1	1	1	1	1
Period 2 - Second Intervention COMPLETED	1	2	1	1	2	1	1	1	1	1	1	1
Period 2 - Second Intervention NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Period 3 - Third Intervention STARTED	1	2	1	1	2	1	1	1	1	1	1	1
Period 3 - Third Intervention COMPLETED	1	2	1	1	2	1	1	1	1	1	1	1
Period 3 - Third Intervention NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Period 4 - Fourth Intervention STARTED	1	2	1	1	2	1	1	1	1	1	1	1
Period 4 - Fourth Intervention COMPLETED	1	2	1	1	2	1	1	1	1	1	1	1
Period 4 - Fourth Intervention NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Population n=14 Participants Summary for overall study population
Age, Continuous	42.1 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United Kingdom	14 participants n=5 Participants

PRIMARY outcome

Timeframe: after fit of each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.

Degree of lens rotation on the eye with the head tilted.

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Lens Orientation During Head Tilt.	12.2 Degree of rotation Standard Deviation 10.7	39.7 Degree of rotation Standard Deviation 18.5	27.6 Degree of rotation Standard Deviation 22.7	39.3 Degree of rotation Standard Deviation 15.9

PRIMARY outcome

Timeframe: after each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.

logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Visual Acuity During Head Tilt	0.02 logMAR units Standard Deviation 0.06	0.15 logMAR units Standard Deviation 0.20	0.07 logMAR units Standard Deviation 0.10	0.11 logMAR units Standard Deviation 0.14

SECONDARY outcome

Timeframe: After each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.

Degree of lens rotation while participant is gazing up.

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Degree of Lens Rotation in Superior Gaze.	3.3 Degree of rotation Standard Deviation 3.8	6.0 Degree of rotation Standard Deviation 4.7	3.7 Degree of rotation Standard Deviation 2.6	6.5 Degree of rotation Standard Deviation 7.0

SECONDARY outcome

Timeframe: After each of 4 lens insertions.,

Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.

Degree of lens rotation while participant is gazing up and out(towards the temple).

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Degree of Lens Rotation in Superior-temporal Gaze.	6.3 Degree of rotation Standard Deviation 5.5	9.4 Degree of rotation Standard Deviation 5.4	4.9 Degree of rotation Standard Deviation 2.3	8.6 Degree of rotation Standard Deviation 5.8

SECONDARY outcome

Timeframe: After each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.

Degree of lens rotation while participant is gazing up and in(towards the nose).

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Degree of Lens Rotation in Superior-nasal Gaze.	6.2 Degree of rotation Standard Deviation 5.4	5.6 Degree of rotation Standard Deviation 3.6	6.9 Degree of rotation Standard Deviation 4.8	5.8 Degree of rotation Standard Deviation 4.9

SECONDARY outcome

Timeframe: After each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.

Degree of lens rotation while participant is gazing out(towards the temple).

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Degree of Lens Rotation in Temporal Gaze.	4.1 Degree of rotation Standard Deviation 3.1	7.2 Degree of rotation Standard Deviation 5.8	2.8 Degree of rotation Standard Deviation 2.2	6.6 Degree of rotation Standard Deviation 5.4

SECONDARY outcome

Timeframe: After each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some lenses.

Degree of lens rotation while participant is gazing in(towards the nose).

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Degree of Lens Rotation in Nasal Gaze.	3.2 Degree of rotation Standard Deviation 3.3	7.1 Degree of rotation Standard Deviation 5.9	2.4 Degree of rotation Standard Deviation 1.3	3.3 Degree of rotation Standard Deviation 3.2

SECONDARY outcome

Timeframe: After each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.

Degree of lens rotation while participant is gazing down and out.

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Degree of Lens Rotation Inferior-temporal Gaze.	3.9 Degree of rotation Standard Deviation 3.9	5.3 Degree of rotation Standard Deviation 4.1	3.7 Degree of rotation Standard Deviation 2.8	2.5 Degree of rotation Standard Deviation 2.3

SECONDARY outcome

Timeframe: After each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.

Degree of lens rotation while participant is gazing down and in.

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Degree of Lens Rotation in Inferior-nasal Gaze.	3.0 Degree of rotation Standard Deviation 1.6	9.0 Degree of rotation Standard Deviation 6.9	5.9 Degree of rotation Standard Deviation 2.9	9.5 Degree of rotation Standard Deviation 5.8

SECONDARY outcome

Timeframe: After each of the four lens insertions

Population: Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.

Degree of lens rotation while participant is gazing down.

Outcome measures

Outcome measures
Measure	Senofilcon A Toric n=13 Participants senofilcon A toric worn in either the first, second, third or fourth periods.	Balafilcon A Toric n=13 Participants balafilcon A toric worn in either the first, second, third or fourth periods	Lotrafilcon B Toric n=13 Participants lotrafilcon B toric worn in either the first, second, third, or fourth periods.	Omafilcon A Toric n=11 Participants omafilcon A toric worn in either the first, second, third, or fourth periods.
Degree of Lens Rotation in Inferior Gaze.	3.9 Degree of rotation Standard Deviation 4.3	5.0 Degree of rotation Standard Deviation 4.0	4.2 Degree of rotation Standard Deviation 6.3	2.4 Degree of rotation Standard Deviation 1.9

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kurt Moody, OD FAAO

Vistakon

Phone: 904-443-3088

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
Publication restrictions are in place

Restriction type: OTHER