AmetropiaNCT00630305

Endothelial Bleb Response With Toric Lenses

A study testing alphafilcon A toric, lotrafilcon B toric and senofilcon A toric in people with Ametropia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.

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

Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Ametropia
What is being tested?: alphafilcon A toric, lotrafilcon B toric and senofilcon A toric
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteAustralia
Study dates: Jan 2008to Jul 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
Healthy volunteers accepted
Adult

Who may be able to join

Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
At least 18 years of age and mentally competent to sign an informed consent form.
Healthy eyes and no use of ocular medication.
Similarity of optical parameters between eyes.
Physical appearance typical of Asian eyes

Who cannot join

A medical or ocular condition that may influence the outcome of this trial.
Current use of ocular/systemic medication that may influence the outcome of this trial.
Failure to wear soft lenses for 2 weeks prior to the start of the study.
Current enrolment or participation in another clinical study.
Current state of pregnancy or breastfeeding
Anisometropia greater than 1.00D (equivalent sphere).
Unequal acuities between eyes (greater than 1 line)
Unequal corneal curvatures (>1.00D)

Trial locations and contacts

1 site in 1 country.

Australia1 site

Brennan Consultants 110 Auburn Rd
Auburn Village, Victoria, 3122

Other trials in Australia

About this study

Official title: Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes

Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state.

Read the detailed description

Interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. An examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. The assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. Lenses will be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at 20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study.

Conditions: Ametropia
Being tested: alphafilcon A toric, lotrafilcon B toric, senofilcon A toric
Keywords: toric, endothelial bleb
Medical subject headings: Refractive Errors

What participants receive

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

alphafilcon A toricDevice
Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).
lotrafilcon B toricDevice
Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).
senofilcon A toricDevice
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).

Study groups in NCT00630305
Study group	Role	What they receive
Session A	Other	Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session A only contains senofilcon A toric and alphafilcon A toric lenses. Receives: Device: alphafilcon A toric; Device: senofilcon A toric
Session B	Other	Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session B only contains senofilcon A toric and alphafilcon A toric lenses. Receives: Device: alphafilcon A toric; Device: senofilcon A toric
Session C	Other	Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session C only contains senofilcon A toric and lotrafilcon B toric lenses. Receives: Device: lotrafilcon B toric; Device: senofilcon A toric
Session D	Other	Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session D only contains senofilcon A toric and lotrafilcon B toric lenses. Receives: Device: lotrafilcon B toric; Device: senofilcon A toric

What is being measured

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

Endothelial Bleb Areas on Cornea: Session A- Open Eye
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Measured: 20 minutes post-lens insertion
Endothelial Bleb Areas on Cornea: Session B- Closed Eye
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Measured: 20 minutes post-lens insertion
Endothelial Bleb Areas on Cornea: Session C- Open Eye
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Measured: 20 minutes post-lens insertion
Endothelial Bleb Areas on Cornea: Session D- Closed Eye
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Measured: 20 minutes post-lens insertion

Timeline

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

Jan 2008Jul 2008

First posted7 Mar 2008 (estimated)
Study startJan 2008
Primary completionJul 2008
Study completionJul 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 AmetropiaStudies 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: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00630305
Sponsor's protocol ID: CR-0726
Other IDs: JJO0717
Status last verified: Jan 2017
First submitted: 28 Feb 2008
Last updated: 3 Mar 2017
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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Recruiting
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All Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes
ClinicalTrials.gov ID: NCT00630305
Acronym / sponsor ID: CR-0726
Conditions: Ametropia
Keywords: toric, endothelial bleb
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 7 Mar 2008 (estimated)
Results: Posted 3 Mar 2017

Clinical summary

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

Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Session A	Other	Device: alphafilcon A toric, Device: senofilcon A toricSubjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session A only contains senofilcon A toric and alphafilcon A toric lenses.
Session B	Other	Device: alphafilcon A toric, Device: senofilcon A toricSubjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session B only contains senofilcon A toric and alphafilcon A toric lenses.
Session C	Other	Device: lotrafilcon B toric, Device: senofilcon A toricSubjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session C only contains senofilcon A toric and lotrafilcon B toric lenses.
Session D	Other	Device: lotrafilcon B toric, Device: senofilcon A toricSubjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session D only contains senofilcon A toric and lotrafilcon B toric lenses.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
At least 18 years of age and mentally competent to sign an informed consent form.
Healthy eyes and no use of ocular medication.
Similarity of optical parameters between eyes.
Physical appearance typical of Asian eyes

Key exclusion criteria (8 listed)

A medical or ocular condition that may influence the outcome of this trial.
Current use of ocular/systemic medication that may influence the outcome of this trial.
Failure to wear soft lenses for 2 weeks prior to the start of the study.
Current enrolment or participation in another clinical study.
Current state of pregnancy or breastfeeding

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
alphafilcon A toricSubjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).	Device	Session A, Session B
lotrafilcon B toricSubjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).	Device	Session C, Session D
senofilcon A toricSubjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).	Device	Session A, Session B, Session C, Session D

Primary outcome

Endothelial Bleb Areas on Cornea: Session A- Open Eye
Time frame: 20 minutes post-lens insertion
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Endothelial Bleb Areas on Cornea: Session B- Closed Eye
Time frame: 20 minutes post-lens insertion
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Endothelial Bleb Areas on Cornea: Session C- Open Eye
Time frame: 20 minutes post-lens insertion
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Endothelial Bleb Areas on Cornea: Session D- Closed Eye
Time frame: 20 minutes post-lens insertion
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.

Results and safety

Results posted to the registry on 3 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	37	35

Primary outcome: Endothelial Bleb Areas on Cornea: Session A- Open Eye

Time frame: 20 minutes post-lens insertion. Mean (Standard Deviation). Unit: Percent Difference of Bleb Area

Measure	Sequence 1 n = 34	Sequence 2 n = 34	Sequence 3 n = 34	Sequence 4 n = 34
Central	0.1 (0.1)	2.0 (0.1)	0.2 (0.1)	2.1 (0.7)
Inferior	0.0 (0.0)	0.8 (0.3)	0.1 (0.0)	2.3 (1.0)
Nasal	0.0 (0.0)	0.1 (0.0)	0.1 (0.0)	0.7 (0.4)
Superior	0.2 (0.1)	0.0 (0.0)	0.0 (0.0)	0.3 (0.1)
Temporal	0.0 (0.0)	0.1 (0.0)	0.1 (0.0)	0.4 (0.2)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.

Primary outcome: Endothelial Bleb Areas on Cornea: Session B- Closed Eye

Time frame: 20 minutes post-lens insertion. Mean (Standard Deviation). Unit: Percent Difference of Bleb Area

Measure	Sequence 1 n = 34	Sequence 2 n = 34	Sequence 3 n = 34	Sequence 4 n = 34
Central	2.0 (0.9)	5.9 (2.5)	4.0 (0.9)	0.9 (0.5)
Inferior	0.5 (0.3)	3.9 (2.2)	2.5 (0.5)	0.9 (0.3)
Nasal	0.5 (0.3)	0.9 (0.1)	1.0 (0.3)	0.1 (0.1)
Superior	0.1 (0.0)	0.2 (0.)	10.3 (0.1)	0.3 (0.1)
Temporal	0.2 (0.1)	0.5 (0.2)	0.5 (0.2)	0.3 (0.1)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.

Primary outcome: Endothelial Bleb Areas on Cornea: Session C- Open Eye

Time frame: 20 minutes post-lens insertion. Mean (Standard Deviation). Unit: Percent Difference of Bleb Area

Measure	Sequence 1 n = 34	Sequence 2 n = 34	Sequence 3 n = 34	Sequence 4 n = 34
Central	0.2 (0.1)	0.4 (0.3)	0.2 (0.1)	0.2 (0.1)
Inferior	0.1 (0.0)	0.1 (0.1)	0.1 (0.0)	0.1 (0.0)
Nasal	0.1 (0.0)	0.1 (0.0)	0.1 (0.0)	0.2 (0.1)
Superior	0.1 (0.0)	0.0 (0.0)	0.0 (0.0)	0.4 (0.1)
Temporal	0.0 (0.0)	0.1 (0.0)	0.0 (0.0)	0.1 (0.0)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.

Primary outcome: Endothelial Bleb Areas on Cornea: Session D- Closed Eye

Time frame: 20 minutes post-lens insertion. Mean (Standard Deviation). Unit: Percent Difference of Bleb Area

Measure	Sequence 1 n = 34	Sequence 2 n = 34	Sequence 3 n = 34	Sequence 4 n = 34
Central	1.7 (0.6)	1.6 (0.6)	0.5 (0.2)	3.5 (2.0)
Inferior	0.8 (0.3)	1.7 (1.0)	0.3 (0.1)	1.4 (0.7)
Nasal	0.2 (0.1)	0.8 (0.4)	0.1 (0.1)	0.7 (0.3)
Superior	0.2 (0.1)	0.1 (0.1)	0.3 (0.2)	0.1 (0.1)
Temporal	0.1 (0.1)	0.2 (0.1)	0.1 (0.0)	0.3 (0.1)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.

Adverse events

Time frame: Throughout the duration of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Session A	0 of 37 (0%)	0 of 37 (0%)	Not reported
Session B	0 of 37 (0%)	0 of 37 (0%)	Not reported
Session C	0 of 37 (0%)	0 of 37 (0%)	Not reported
Session D	0 of 37 (0%)	0 of 37 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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.

Noel A Brennan, McOptom PhD principal investigator

Brennan Consultants

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

Questions about this trial

What is this clinical trial studying?

A study testing alphafilcon A toric, lotrafilcon B toric and senofilcon A toric in people with Ametropia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.

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 3 Mar 2017. 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 Australia. 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 3 Mar 2017). 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?

Endothelial Bleb Areas on Cornea: Session A- Open Eye (time frame: 20 minutes post-lens insertion). The study lists 4 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 NCT00630305.

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 3 Mar 2017.