AstigmatismNCT00583908

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

A study testing senofilcon A, balafilcon A toric and lotrafilcon B toric in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Astigmatism
What is being tested?: senofilcon A, balafilcon A toric and lotrafilcon B toric
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2007to Jan 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.-

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Visioncare Research Ltd.
Farnham, GU9 7EN

Other trials in United Kingdom

About this study

Official title: Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3

Read the detailed description

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

Conditions: Astigmatism
Being tested: senofilcon A, balafilcon A toric, lotrafilcon B toric, omafilcon A
Keywords: astigmatism, orientation, visual acuity, contact lenses
Medical subject headings: Astigmatism, Orientation, Spatial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

senofilcon ADevice
toric contact lens
balafilcon A toricDevice
toric contact lens
lotrafilcon B toricDevice
toric contact lens
omafilcon ADevice
toric contact lens

Study groups in NCT00583908
Study group	Role	What they receive
Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A
Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Jan 2008

First posted2 Jan 2008 (estimated)
Study startNov 2007
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AstigmatismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00583908
Sponsor's protocol ID: CR-0710 pt 3
Other IDs: ETOR-507(under GNR-011)
Status last verified: May 2015
First submitted: 21 Dec 2007
Last updated: 21 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
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The EYERISING Study
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P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3
ClinicalTrials.gov ID: NCT00583908
Acronym / sponsor ID: CR-0710 pt 3
Conditions: Astigmatism
Keywords: astigmatism, orientation, visual acuity, contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: Visioncare Research Ltd.
Study start: Nov 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 2 Jan 2008 (estimated)
Results: Posted 28 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 12

Arm	Type	Receives
Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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	Active comparator	Device: senofilcon A, Device: balafilcon A toric, Device: lotrafilcon B toric, Device: omafilcon AOne 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

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
senofilcon Atoric contact lens	Device	Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A, Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B, Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A, Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A, Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A, Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A, Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A, Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B, Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A, Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A, Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A, Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A
balafilcon A torictoric contact lens	Device	Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A, Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B, Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A, Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A, Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A, Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A, Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A, Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B, Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A, Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A, Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A, Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A
lotrafilcon B torictoric contact lens	Device	Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A, Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B, Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A, Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A, Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A, Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A, Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A, Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B, Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A, Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A, Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A, Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A
omafilcon Atoric contact lens	Device	Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A, Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B, Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A, Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A, Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A, Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A, Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A, Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B, Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A, Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A, Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A, Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A

Primary outcome

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

8 secondary outcomes

Degree of Lens Rotation in Superior Gaze.
Time frame: After each of the four lens insertions
Degree of Lens Rotation in Superior-temporal Gaze.
Time frame: After each of 4 lens insertions.,
Degree of Lens Rotation in Superior-nasal Gaze.
Time frame: After each of the four lens insertions
Degree of Lens Rotation in Temporal Gaze.
Time frame: After each of the four lens insertions
Degree of Lens Rotation in Nasal Gaze.
Time frame: After each of the four lens insertions
Degree of Lens Rotation Inferior-temporal Gaze.
Time frame: After each of the four lens insertions
Degree of Lens Rotation in Inferior-nasal Gaze.
Time frame: After each of the four lens insertions
Degree of Lens Rotation in Inferior Gaze.
Time frame: After each of the four lens insertions

Results and safety

Results posted to the registry on 28 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A	1	1
Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A	2	2
Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A	1	1
Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A	1	1
Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B	2	2
Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A	1	1
Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A	1	1
Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A	1	1
Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A	1	1
Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A	1	1
Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A	1	1
Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A	1	1

Primary outcome: Lens Orientation During Head Tilt.

Time frame: after fit of each of the four lens insertions. Mean (Standard Deviation). Unit: Degree of rotation

Measure	Senofilcon A Toric n = 13	Balafilcon A Toric n = 13	Lotrafilcon B Toric n = 13	Omafilcon A Toric n = 11
Value	12.2 (10.7)	39.7 (18.5)	27.6 (22.7)	39.3 (15.9)

Senofilcon A Toric vs Balafilcon A Toric: Mean Difference (Final Values): -27.5, p <0.0001, t-test, 1 sided
Senofilcon A Toric vs Lotrafilcon B Toric: Mean Difference (Final Values): -15.4, p = 0.0002, t-test, 1 sided
Senofilcon A Toric vs Omafilcon A Toric: Mean Difference (Final Values): -27.0, p <0.0001, t-test, 1 sided

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

Primary outcome: Visual Acuity During Head Tilt

Time frame: after each of the four lens insertions. Mean (Standard Deviation). Unit: logMAR units

Measure	Senofilcon A Toric n = 13	Balafilcon A Toric n = 13	Lotrafilcon B Toric n = 13	Omafilcon A Toric n = 11
Value	0.02 (0.06)	0.15 (0.20)	0.07 (0.10)	0.11 (0.14)

Senofilcon A Toric vs Balafilcon A Toric: Mean Difference (Final Values): -0.13, p = 0.0083, t-test, 1 sided
Senofilcon A Toric vs Lotrafilcon B Toric: Mean Difference (Final Values): -0.06, p = 0.052, t-test, 1 sided
Senofilcon A Toric vs Omafilcon A Toric: Mean Difference (Final Values): -0.13, p = 0.015, t-test, 1 sided

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

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A	0 of 2 (0%)	0 of 1 (0%)	Not reported
Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B	0 of 1 (0%)	0 of 1 (0%)	Not reported
Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported
Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A	0 of 1 (0%)	0 of 1 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Graeme Young, BSc, MPhil principal investigator

Visioncare Research Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A, balafilcon A toric and lotrafilcon B toric in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lens Orientation During Head Tilt. (time frame: after fit of each of the four lens insertions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00583908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.