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

Not Applicable

Completed

Conditions: Astigmatism

Interventions: Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A

Registration Number: NCT00583908

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary: The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.

Detailed Description: Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, \~2 hour duration.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

Inclusion Criteria

be at least 18 and less than or equal to 50 years of age
be able and willing to adhere to the instructions set forth in the protocol.
have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
Sign the STATEMENT OF INFORMED CONSENT.
Have normal, healthy eyes

Exclusion Criteria

The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
Pre-existing ocular disease precluding contact lens fitting.
Insufficient lacrimal secretions
Aphakia, keratoconus or a highly irregular cornea
Previous eye surgery involving the anterior segment
Current pregnancy or lactation (to the best of the subject's knowledge).
Use of concurrent ocular medication
Active participation in another clinical study at any time during this study.-

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A
Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A
Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A
Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B
Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B
Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A
Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A
Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A
Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A
Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A
Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A
Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A
Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A
Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A
Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A
Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A
Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B
Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B
Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A
Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A
Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A
Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A
Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A
Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A
Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A
Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A
Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B
Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A
Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A
Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A
Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A
Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A
Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B
Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A
Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A
Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A
Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B	senofilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B
Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A	balafilcon A toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A
Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A	lotrafilcon B toric	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A
Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B
Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A	omafilcon A	One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A

Primary Outcome Measures

Name	Time	Method
Visual Acuity During Head Tilt	after each of the four lens insertions	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.
Lens Orientation During Head Tilt.	after fit of each of the four lens insertions	Degree of lens rotation on the eye with the head tilted.

Secondary Outcome Measures

Name	Time	Method
Degree of Lens Rotation in Temporal Gaze.	After each of the four lens insertions	Degree of lens rotation while participant is gazing out(towards the temple).
Degree of Lens Rotation in Superior Gaze.	After each of the four lens insertions	Degree of lens rotation while participant is gazing up.
Degree of Lens Rotation in Superior-temporal Gaze.	After each of 4 lens insertions.,	Degree of lens rotation while participant is gazing up and out(towards the temple).
Degree of Lens Rotation in Inferior Gaze.	After each of the four lens insertions	Degree of lens rotation while participant is gazing down.
Degree of Lens Rotation Inferior-temporal Gaze.	After each of the four lens insertions	Degree of lens rotation while participant is gazing down and out.
Degree of Lens Rotation in Superior-nasal Gaze.	After each of the four lens insertions	Degree of lens rotation while participant is gazing up and in(towards the nose).
Degree of Lens Rotation in Nasal Gaze.	After each of the four lens insertions	Degree of lens rotation while participant is gazing in(towards the nose).
Degree of Lens Rotation in Inferior-nasal Gaze.	After each of the four lens insertions	Degree of lens rotation while participant is gazing down and in.