HyperopiaNCT01228591

Pilot Dispensing Evaluation of a Plus Power Lens

A study testing Acuvue Advance Plus and Acuvue Advance in people with Hyperopia, run by Johnson & Johnson Vision Care, Inc. at 3 sites in United States.

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 compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Hyperopia
What is being tested?: Acuvue Advance Plus and Acuvue Advance
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 3 sitesUnited States
Study dates: Oct 2010to Nov 2010
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The subject must be at least 18 years of age and no more than 45 years of age.
The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
Any cylinder power must be ≤ 0.75D.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
The subject must read and sign the Statement of Informed Consent.
The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Who cannot join

Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

Show all 11Show fewer

Pregnancy or lactation.
Diabetes.
Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
Need any near correction.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Nanticoke, Pennsylvania
Study site
New York, New York
Study site
Winter Park, Florida

Other trials in United States

About this study

The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.

Conditions: Hyperopia
Being tested: Acuvue Advance Plus, Acuvue Advance
Medical subject headings: Hyperopia

What participants receive

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

Acuvue Advance PlusDevice
Silicone hydrogel contact lens.
Acuvue AdvanceDevice
Silicone hydrogel contact lens

Study groups in NCT01228591
Study group	Role	What they receive
Acuvue Advance Plus/ Acuvue Advance	Other	Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second. Receives: Device: Acuvue Advance Plus; Device: Acuvue Advance
Acuvue Advance/Acuvue Advance Plus	Other	Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second. Receives: Device: Acuvue Advance Plus; Device: Acuvue Advance

What is being measured

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

Visual Acuity One Week After Lens Wear
Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.
Measured: 1 week
Visual Acuity at Time of Initial Fit
Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
Measured: After 10-15 minutes of lens wear

Secondary outcomes (4)

Contact Lens Comfort Using Contact Lens User Experience (CLUE)
The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
Measured: 1 week
Subject Reported Vision Using Contact Lens User Experience (CLUE).
Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
Measured: 1 week
Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)
Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120.
Measured: Baseline
Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)
Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
Measured: Baseline

Timeline

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

Oct 2010Nov 2010

First posted26 Oct 2010 (estimated)
Study startOct 2010
Primary completionNov 2010
Study completionNov 2010

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 HyperopiaStudies 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: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01228591
Sponsor's protocol ID: CR-1636BB
Status last verified: May 2015
First submitted: 22 Oct 2010
Last updated: 19 Jun 2018
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 Hyperopia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Dispensing Evaluation of a Plus Power Lens
ClinicalTrials.gov ID: NCT01228591
Acronym / sponsor ID: CR-1636BB
Conditions: Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 26 Oct 2010 (estimated)
Results: Posted 3 Feb 2014

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 the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Acuvue Advance Plus/ Acuvue Advance	Other	Device: Acuvue Advance Plus, Device: Acuvue AdvanceAcuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
Acuvue Advance/Acuvue Advance Plus	Other	Device: Acuvue Advance Plus, Device: Acuvue AdvanceAcuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

The subject must be at least 18 years of age and no more than 45 years of age.
The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
Any cylinder power must be ≤ 0.75D.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.

Key exclusion criteria (11 listed)

Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
Any ocular infection.

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
Acuvue Advance PlusSilicone hydrogel contact lens.	Device	Acuvue Advance Plus/ Acuvue Advance, Acuvue Advance/Acuvue Advance Plus
Acuvue AdvanceSilicone hydrogel contact lens	Device	Acuvue Advance Plus/ Acuvue Advance, Acuvue Advance/Acuvue Advance Plus

Primary outcome

Visual Acuity One Week After Lens Wear
Time frame: 1 week
Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.
Visual Acuity at Time of Initial Fit
Time frame: After 10-15 minutes of lens wear
Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.

4 secondary outcomes

Contact Lens Comfort Using Contact Lens User Experience (CLUE)
Time frame: 1 week
Subject Reported Vision Using Contact Lens User Experience (CLUE).
Time frame: 1 week
Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)
Time frame: Baseline
Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)
Time frame: Baseline

Results and safety

Results posted to the registry on 3 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acuvue Advance Plus/ Acuvue Advance	18	17
Acuvue Advance/ Acuvue Advance Plus	18	16

Primary outcome: Visual Acuity One Week After Lens Wear

Time frame: 1 week. Least squares mean (Standard Error). Unit: LogMAR

Measure	Acuvue Advance Plus n = 33	Acuvue Advance n = 33
Low Luminance/ High Contrast (Binocular)	0.11 (0.082)	0.10 (0.063)
Low Luminance/ High Contrast (Monocular)	0.14 (0.100)	0.14 (0.088)
High Luminance/ Low Contrast (Binocular)	0.12 (0.075)	0.13 (0.067)
High Luminance/ Low Contrast (Monocular)	0.22 (0.108)	0.21 (0.097)

Acuvue Advance Plus vs Acuvue Advance: Mean Difference (Final Values): 0.007 (95% CI -0.0044 to 0.0187), Mixed Models Analysis
Acuvue Advance Plus vs Acuvue Advance: Mean Difference (Final Values): 0.003 (95% CI -0.0086 to 0.0146), Mixed Models Analysis

Population analysed: Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis.

Primary outcome: Visual Acuity at Time of Initial Fit

Time frame: After 10-15 minutes of lens wear. Mean (Standard Deviation). Unit: LogMAR

Measure	Acuvue Advance Plus n = 33	Acuvue Advance n = 33
Low Luminance/High Contrast (Binocular)	0.13 (0.087)	0.11 (0.073)
Low Luminance/High Contrast (Monocular)	0.16 (0.106)	0.15 (0.101)
High Luminance/Low Contrast (Binocular)	0.14 (0.076)	0.13 (0.094)
High Luminance/Low Contrast (Monocular)	0.24 (0.123)	0.21 (0.111)

Acuvue Advance Plus vs Acuvue Advance: Mean Difference (Final Values): 0.016 (95% CI 0.0041 to 0.0282), Mixed Models Analysis
Acuvue Advance Plus vs Acuvue Advance: Mean Difference (Final Values): 0.021 (95% CI 0.0090 to 0.3305), Mixed Models Analysis

Population analysed: Analysis is conducted on those were enrolled and completed the trial.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month, Study took place from Oct 1, 2010-Nov 12, 2010. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acuvue Advance Plus	0 of 33 (0%)	0 of 33 (0%)	Not reported
Acuvue Advance	0 of 33 (0%)	0 of 33 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperopia

Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
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Not yet recruiting
The Emmetropization Via Accommodation (EVA) - II Study
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Recruiting
Eye Imaging for the Study of Childhood Myopia
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Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
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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.

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Acuvue Advance Plus and Acuvue Advance in people with Hyperopia, run by Johnson & Johnson Vision Care, Inc. at 3 sites in United States.

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 7 inclusion and 11 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 Feb 2014). 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?

Visual Acuity One Week After Lens Wear (time frame: 1 week). 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 NCT01228591.

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 19 Jun 2018.