MyopiaNCT00762788

Clinical Trial of Several Contact Lenses in Extended Wear

A study testing senofilcon A, lotrafilcon A and lotrafilcon B in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in India.

Completed

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

Official record

Search all trials

Trial summary

The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights. Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Myopia
What is being tested?: senofilcon A, lotrafilcon A and lotrafilcon B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 1 siteIndia
Study dates: Feb 2007to Sep 2009
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 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Be of legal age, and be between 18 and 39 years of age.
Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Require a visual correction in both eyes (Monovision not allowed)
Require a soft contact lens spherical correction between -0.50 and -9.00D.
Have an astigmatic correction less than 1.50D in both eyes.
Be able to wear the lens powers available for this study.

Show all 14Show fewer

Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week)
Be correctable to a visual acuity of 20/30 or better in each eye.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia.
No evidence of lid abnormality or infection.
No clinically significant slit lamp findings
No other active ocular disease.
No previous ocular surgery.

Who cannot join

Requires concurrent ocular medication.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
PMMA or RGP lens wear in the previous 8 weeks.

Show all 15Show fewer

Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
Abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrollment only.
Participation in any concurrent clinical trial.
Currently wearing B\&L PureVision, Ciba O2 Optix, Ciba Night \& Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis
Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related).
Has had an eye injury or surgery within the last eight weeks.

Trial locations and contacts

1 site in 1 country.

India1 site

Vision Research Foundation
Chennai, Tamil Nadu, 600 006

Other trials in India

About this study

The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.

Conditions: Myopia
Being tested: senofilcon A, lotrafilcon A, lotrafilcon B, balafilcon A, comfilcon A
Medical subject headings: Myopia

What participants receive

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

senofilcon ADevice
1 week extended wear contact lens
lotrafilcon ADevice
1 week extended wear contact lens
lotrafilcon BDevice
1 week extended wear contact lens
balafilcon ADevice
1 week extended wear contact lens
comfilcon ADevice
1 week extended wear contact lens
etafilcon ADevice
1 week extended wear contact lens

Study groups in NCT00762788
Study group	Role	What they receive
senofilcon A contact lens	Active comparator	ACUVUE OASYS Receives: Device: senofilcon A
lotrafilcon A contact lens	Active comparator	NIGHT\&DAY Receives: Device: lotrafilcon A
lotrafilcon B contact lens	Active comparator	O2Optix Receives: Device: lotrafilcon B
balafilcon A contact lens	Active comparator	PureVision Receives: Device: balafilcon A
comfilcon A contact lens	Active comparator	Biofinity Receives: Device: comfilcon A
etafilcon A contact lens	Active comparator	ACUVUE 2 Receives: Device: etafilcon A

What is being measured

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

Incidence of Corneal Infiltrative Events
Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
Measured: 52 weeks
Incidence of Adverse Events
Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
Measured: 52 weeks

Timeline

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

Feb 2007Sep 2009

First posted30 Sep 2008 (estimated)
Study startFeb 2007
Primary completionSep 2009
Study completionSep 2009

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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00762788
Sponsor's protocol ID: CR-4472
Status last verified: Jun 2015
First submitted: 26 Sep 2008
Last updated: 29 Jun 2015
Results posted: Yes, on ClinicalTrials.gov

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

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 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial of Several Contact Lenses in Extended Wear
ClinicalTrials.gov ID: NCT00762788
Acronym / sponsor ID: CR-4472
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 15 May 2015

Clinical summary

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

The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 6

Arm	Type	Receives
senofilcon A contact lens	Active comparator	Device: senofilcon AACUVUE OASYS
lotrafilcon A contact lens	Active comparator	Device: lotrafilcon ANIGHT\&DAY
lotrafilcon B contact lens	Active comparator	Device: lotrafilcon BO2Optix
balafilcon A contact lens	Active comparator	Device: balafilcon APureVision
comfilcon A contact lens	Active comparator	Device: comfilcon ABiofinity
etafilcon A contact lens	Active comparator	Device: etafilcon AACUVUE 2

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Be of legal age, and be between 18 and 39 years of age.
Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Require a visual correction in both eyes (Monovision not allowed)
Require a soft contact lens spherical correction between -0.50 and -9.00D.
Have an astigmatic correction less than 1.50D in both eyes.

Key exclusion criteria (15 listed)

Requires concurrent ocular medication.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

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 A1 week extended wear contact lens	Device	senofilcon A contact lens
lotrafilcon A1 week extended wear contact lens	Device	lotrafilcon A contact lens
lotrafilcon B1 week extended wear contact lens	Device	lotrafilcon B contact lens
balafilcon A1 week extended wear contact lens	Device	balafilcon A contact lens
comfilcon A1 week extended wear contact lens	Device	comfilcon A contact lens
etafilcon A1 week extended wear contact lens	Device	etafilcon A contact lens

Primary outcome

Incidence of Corneal Infiltrative Events
Time frame: 52 weeks
Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
Incidence of Adverse Events
Time frame: 52 weeks
Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.

Results and safety

Results posted to the registry on 15 May 2015, 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 Contact Lens	55	29
Lotrafilcon A Contact Lens	58	21
Lotrafilcon B Contact Lens	42	21
Balafilcon A Contact Lens	64	38
Comfilcon A Contact Lens	43	30
Etafilcon A Contact Lens	52	31

Primary outcome: Incidence of Corneal Infiltrative Events

Time frame: 52 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Senofilcon A Contact Lens n = 55	Lotrafilcon A Contact Lens n = 58	Lotrafilcon B Contact Lens n = 42	Balafilcon A Contact Lens n = 64	Comfilcon A Contact Lens n = 43	Etafilcon A Contact Lens n = 52
Value	31 (20 to 44)	16 (8 to 27)	10 (4 to 22)	8 (3 to 17)	33 (20 to 47)	10 (4 to 21)

Population analysed: Subjects who were enrolled and dispensed lenses.

Primary outcome: Incidence of Adverse Events

Time frame: 52 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Senofilcon A Contact Lens n = 55	Lotrafilcon A Contact Lens n = 58	Lotrafilcon B Contact Lens n = 42	Balafilcon A Contact Lens n = 64	Comfilcon A Contact Lens n = 43	Etafilcon A Contact Lens n = 52
Value	35 (23 to 48)	24 (15 to 37)	19 (10 to 33)	31 (21 to 43)	37 (24 to 52)	12 (5 to 23)

Population analysed: Subjects who were enrolled and dispensed lenses.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A Contact Lens	1 of 55 (1.8%)	27 of 55 (49.1%)	Not reported
Lotrafilcon A Contact Lens	0 of 58 (0%)	17 of 58 (29.3%)	Not reported
Lotrafilcon B Contact Lens	0 of 42 (0%)	10 of 42 (23.8%)	Not reported
Balafilcon A Contact Lens	0 of 64 (0%)	23 of 64 (35.9%)	Not reported
Comfilcon A Contact Lens	1 of 43 (2.3%)	18 of 43 (41.9%)	Not reported
Etafilcon A Contact Lens	0 of 52 (0%)	8 of 52 (15.4%)	Not reported

Limitations and caveats (from the sponsor): Cautions for results: low completed enrollment numbers and number of non-neophytes lower than required per protocol. Arms not gender matched; Proportion of neophytes/non-neophytes not balanced; High rate of drop-out among subjects enrolled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
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.

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, lotrafilcon A and lotrafilcon B in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in India.

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 14 inclusion and 15 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 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 India. 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 15 May 2015). 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?

Incidence of Corneal Infiltrative Events (time frame: 52 weeks). 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 NCT00762788.

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 2015.