MyopiaNCT00808834

Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

A study testing Lotrafilcon A contact lens and Senofilcon A contact lens in people with Myopia, run by CIBA VISION.

Completed

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

Trial summary

The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear. Read more about this study

Who is it for?: Any age
Conditions the study is for: Myopia
What is being tested?: Lotrafilcon A contact lens and Senofilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: No sites listed yet
Study dates: Nov 2008to Dec 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Currently wearing soft contact lenses
Replaces lenses on a weekly or longer schedule
Other protocol-defined inclusion/exclusion criteria may apply

Who cannot join

Requires concurrent ocular medication
Eye injury or surgery within twelve weeks immediately prior to enrollment
Currently wearing soft toric lens wearers
Those who dispose of their soft lenses on a daily basis
Other protocol-defined inclusion/exclusion criteria may apply

About this study

The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.

Conditions: Myopia
Being tested: Lotrafilcon A contact lens, Senofilcon A contact lens
Medical subject headings: Myopia

What participants receive

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

Lotrafilcon A contact lensDevice
Investigational, silicone hydrogel, spherical, soft contact lens
Senofilcon A contact lensDevice
Commercially marketed, silicone hydrogel, spherical, soft contact lens

Study groups in NCT00808834
Study group	Role	What they receive
Senofilcon A / Lotrafilcon A	Other	Senofilcon A, followed by Lotrafilcon A Receives: Device: Lotrafilcon A contact lens; Device: Senofilcon A contact lens
Lotrafilcon A / Senofilcon A	Other	Lotrafilcon A, followed by Senofilcon A Receives: Device: Lotrafilcon A contact lens; Device: Senofilcon A contact lens

What is being measured

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

Comfort After Insertion
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 30-60 seconds after initial insertion

Timeline

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

Nov 2008Dec 2008

First posted16 Dec 2008 (estimated)
Study startNov 2008
Primary completionDec 2008
Study completionDec 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 MyopiaStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808834
Sponsor's protocol ID: P-335-C-008
Status last verified: Jan 2012
First submitted: 11 Dec 2008
Last updated: 29 Jun 2012
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?

Official record

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
ClinicalTrials.gov ID: NCT00808834
Acronym / sponsor ID: P-335-C-008
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 16 Dec 2008 (estimated)
Results: Posted 4 Oct 2010

Clinical summary

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

The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Senofilcon A / Lotrafilcon A	Other	Device: Lotrafilcon A contact lens, Device: Senofilcon A contact lensSenofilcon A, followed by Lotrafilcon A
Lotrafilcon A / Senofilcon A	Other	Device: Lotrafilcon A contact lens, Device: Senofilcon A contact lensLotrafilcon A, followed by Senofilcon A

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Currently wearing soft contact lenses
Replaces lenses on a weekly or longer schedule
Other protocol-defined inclusion/exclusion criteria may apply

Key exclusion criteria (5 listed)

Requires concurrent ocular medication
Eye injury or surgery within twelve weeks immediately prior to enrollment
Currently wearing soft toric lens wearers
Those who dispose of their soft lenses on a daily basis
Other protocol-defined inclusion/exclusion criteria may apply

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
Lotrafilcon A contact lensInvestigational, silicone hydrogel, spherical, soft contact lens	Device	Lotrafilcon A / Senofilcon A, Senofilcon A / Lotrafilcon A
Senofilcon A contact lensCommercially marketed, silicone hydrogel, spherical, soft contact lens	Device	Lotrafilcon A / Senofilcon A, Senofilcon A / Lotrafilcon A

Primary outcome

Comfort After Insertion
Time frame: 30-60 seconds after initial insertion
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.

Results and safety

Results posted to the registry on 4 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Senofilcon A / Lotrafilcon A	97	97
Lotrafilcon A / Senofilcon A	99	99

Primary outcome: Comfort After Insertion

Time frame: 30-60 seconds after initial insertion. Mean (Standard Deviation). Unit: Scale 1-10

Measure	Senofilcon A n = 193	Lotrafilcon A n = 193
Value	8.7 (1.5)	7.7 (2.4)

Population analysed: Per protocol

Adverse events

Time frame: 30 days, duration of the trial.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A	0 of 196 (0%)	0 of 196 (0%)	Not reported
Lotrafilcon A	0 of 196 (0%)	0 of 196 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon A contact lens and Senofilcon A contact lens in people with Myopia, run by CIBA VISION.

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 3 inclusion and 5 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 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

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 4 Oct 2010). 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?

Comfort After Insertion (time frame: 30-60 seconds after initial insertion). 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 NCT00808834.

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 29 Jun 2012.