HyperopiaNCT01996787

Clinical Study of Visibility Tinted Clariti Contact Lens

A study testing Air Optix Aqua and Clariti with Handling Tint in people with Hyperopia and Myopia, run by Sauflon Pharmaceuticals Ltd 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

Search all trials

Trial summary

The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals Limited) by comparison with Air Optix Aqua silicone hydrogel lenses (Alcon Inc.) Subjects used OptiFree Replenish solution (Alcon Lboratories… Read more about this study

Who is it for?: Ages 19 to 56 yearsHealthy volunteers can take part
Conditions the study is for: Hyperopia, Myopia
What is being tested?: Air Optix Aqua and Clariti with Handling Tint
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited Kingdom
Study dates: Jun 2013to Sep 2013
Phase: Interventional
Are there results?: None posted in the registry

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 19 to 56 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

They are 18 years of age and above
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent
They are willing and able to follow the protocol
The agree not to paticipate in other clinical research for the duration of this study
They have a best spectacle corrected visual acuity greater or equal to 20/25 (logMAR 0.1)
They have a manifest cylinder less than or equal to 0.75D

Show all 9Show fewer

They have successfully worn contact lenses within six months of starting the study
They can be fitted with spherical soft contact lenses within the power range available
They are willing to wear the study lenses for a minimum of four days a week, six hours a day

Who cannot join

They have any active anterior segment ocular disease which would normally contraindicate contact lens wear
They have any anterior segment infection, inflammation or abnormality
They use any systemic medications which would normally contraindicate contact lens wear
They are using any ocular medications
They have a history of herpetic keratitis
They have a systemic disorder which would normally contraindicate contact lens wear

Show all 14Show fewer

They have any infectious disease (e.g. Hepatitis) or any immunosuppressive disease (e.g. HIV)
They have glaucoma (high pressure in the eye), have had cataract surgery or a history of recurring abrasions
They have had corneal refractive surgery or they have an irregular cornea
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus
They are pregnant or lactating
They have any slit lamp findings which are more serious than grade 1
They have a history of anaphylaxis or severe allergic reactions
They have taken part in any other contact lens or contact lens care product clinical trial or research, within two weeks prior to starting this study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research Faculty of Life Sciences The University of Manchester
Manchester, Manchester, M60 1QD

Other trials in United Kingdom

About this study

Official title: The Clinical Performance of the Clariti Contact Lens (Including Handling Tint) for Daily Wear

Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens maintenance, care and storage.

Read the detailed description

Study characteristics:

The clinical study evaluates the clinical performance of a silicone hydrogel contact lens for daily wear, Clariti (including handling tint) (Sauflon Pharmaceuticals Ltd.) versus a predicate device, Air Optix Aqua (Alcon Inc.), in terms of lens performance, physiological response and subjective acceptance.

Subjects used OptiFRee Replenish solution (Alcon Laboratories Inc.) for daily lens maintenance, care and storage.

The key features were as follows:

One month duration.
Three investigator sites.
Daily wear soft (hydrophilic) silicone hydrogel contact lenses, replaced on a monthly basis: Clariti Monthly (with handling tint)and Air Optix Aqua. Replenish was used as a care system by all subjects.
A total of 38 subjects were enrolled, and 38 subjects accounted for 76 eyes were dispensed lenses. This group was randomized into 25 test subjects (50 eyes) and 13 control subjects (26 eyes).
Of the 25 test subjects, 25 (100%) completed one month of use. Of the 13 control subjects, 12 (92.3%)completed one month of use.
There were no adverse reactions.

II. Study period:

The study was conducted over one month of wear. Subjects were examined initially, and at two follow-up visits after two weeks and four weeks respectively. Study visits commenced on June 26, 2013 and completed on September 14, 2013.

Conditions: Hyperopia, Myopia
Being tested: Air Optix Aqua, Clariti with Handling Tint
Keywords: visibility tinted silicone hydrogel contact lenses for daily wear
Medical subject headings: Hyperopia, Myopia

What participants receive

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

Air Optix AquaDevice
Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
Clariti with Handling TintDevice
Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.

Study groups in NCT01996787
Study group	Role	What they receive
Air Optix Aqua	Active comparator	Compare safety and efficacy of the lens using OptiFree Replenish solution Receives: Device: Air Optix Aqua; Device: Clariti with Handling Tint
Clariti with Handling Tint	Active comparator	Compare safety and efficacy of the lens using OptiFree Replenish solution Receives: Device: Air Optix Aqua; Device: Clariti with Handling Tint

What is being measured

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

Slit lamp Biomicroscopy
Slit Lamp examination will be performed at the initial and follow-up visits. Slit lamp findings will be graded on a 0-4 scale (0=none;4=severe).
Measured: 1 month
Adverse reactions
Adverse reactions will be recorded throughout the study. Adverse recations will be classified as serious, significant and non-significant.
Measured: 1 month
Wear Time
Lens wear time is recorded for the two study lenses at follow-up visits.
Measured: 1 month
Visual Acuity
LogMAR Visual Acuity at high contrast will be recorded before and after performeing an over-refraction at the initial, two-week and one-month visits.
Measured: 1 month

Secondary outcomes (5)

Subjective Scores
Subjective scores for comfort, vision, handling and overall score will be recorded at the initial and follow-up visits. The subjective scores will be graded on a 0-5 scale.
Measured: 1 month
Symptoms, problems and complaints
The presence or absence of symptoms, problems and complaints will be recorded at two-weeks and one-month visits.
Measured: 1 month
Discontinuations
All subjects discontinuations will be recorded at the two-week and one-month visits.
Measured: 1 month
Refraction
Refraction was undertaken and recorded for all subjects at the initial, two-weeks and one-month visits.
Measured: 1 month
Keratometry
Keratometry measures will be performed at the initial and one-month visits for all subjects.
Measured: 1 month

Timeline

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

Jun 2013Sep 2013

First posted27 Nov 2013 (estimated)
Study startJun 2013
Primary completionJul 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01996787
Sponsor's protocol ID: S13-540
Status last verified: Nov 2013
First submitted: 7 Nov 2013
Last updated: 27 Nov 2013
Results posted: No
Data monitoring committee: No

Publications

Varikooty J, Keir N, Richter D, Jones LW, Woods C, Fonn D. Comfort response of three silicone hydrogel daily disposable contact lenses. Optom Vis Sci. 2013 Sep;90(9):945-53. doi: 10.1097/OPX.0b013e31829d8dbf.
PubMed 23892493
Belda-Salmeron L, Ferrer-Blasco T, Albarran-Diego C, Madrid-Costa D, Montes-Mico R. Diurnal variations in visual performance for disposable contact lenses. Optom Vis Sci. 2013 Jul;90(7):682-90. doi: 10.1097/OPX.0b013e318299088f.
PubMed 23770656
Montes-Mico R, Belda-Salmeron L, Ferrer-Blasco T, Albarran-Diego C, Garcia-Lazaro S. On-eye optical quality of daily disposable contact lenses for different wearing times. Ophthalmic Physiol Opt. 2013 Sep;33(5):581-91. doi: 10.1111/opo.12044. Epub 2013 Mar 19.
PubMed 23510388

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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All Hyperopia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Performance of the Clariti Contact Lens (Including Handling Tint) for Daily Wear
ClinicalTrials.gov ID: NCT01996787
Acronym / sponsor ID: S13-540
Conditions: Hyperopia, Myopia
Keywords: visibility tinted silicone hydrogel contact lenses for daily wear
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Sauflon Pharmaceuticals LtdIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Jul 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 27 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens maintenance, care and storage.

Detailed description

Study characteristics:

Subjects used OptiFRee Replenish solution (Alcon Laboratories Inc.) for daily lens maintenance, care and storage.

The key features were as follows:

One month duration.
Three investigator sites.
Daily wear soft (hydrophilic) silicone hydrogel contact lenses, replaced on a monthly basis: Clariti Monthly (with handling tint)and Air Optix Aqua. Replenish was used as a care system by all subjects.
A total of 38 subjects were enrolled, and 38 subjects accounted for 76 eyes were dispensed lenses. This group was randomized into 25 test subjects (50 eyes) and 13 control subjects (26 eyes).
Of the 25 test subjects, 25 (100%) completed one month of use. Of the 13 control subjects, 12 (92.3%)completed one month of use.
There were no adverse reactions.

II. Study period:

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Air Optix Aqua	Active comparator	Device: Air Optix Aqua, Device: Clariti with Handling TintCompare safety and efficacy of the lens using OptiFree Replenish solution
Clariti with Handling Tint	Active comparator	Device: Air Optix Aqua, Device: Clariti with Handling TintCompare safety and efficacy of the lens using OptiFree Replenish solution

Who may qualify

Ages: 19 to 56 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

They are 18 years of age and above
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent
They are willing and able to follow the protocol
The agree not to paticipate in other clinical research for the duration of this study
They have a best spectacle corrected visual acuity greater or equal to 20/25 (logMAR 0.1)

Key exclusion criteria (14 listed)

They have any active anterior segment ocular disease which would normally contraindicate contact lens wear
They have any anterior segment infection, inflammation or abnormality
They use any systemic medications which would normally contraindicate contact lens wear
They are using any ocular medications
They have a history of herpetic keratitis

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
Air Optix AquaLenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.	Device	Air Optix Aqua, Clariti with Handling Tint
Clariti with Handling TintLenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.	Device	Air Optix Aqua, Clariti with Handling Tint

Primary outcome

Slit lamp Biomicroscopy
Time frame: 1 month
Slit Lamp examination will be performed at the initial and follow-up visits. Slit lamp findings will be graded on a 0-4 scale (0=none;4=severe).
Adverse reactions
Time frame: 1 month
Adverse reactions will be recorded throughout the study. Adverse recations will be classified as serious, significant and non-significant.
Wear Time
Time frame: 1 month
Lens wear time is recorded for the two study lenses at follow-up visits.
Visual Acuity
Time frame: 1 month
LogMAR Visual Acuity at high contrast will be recorded before and after performeing an over-refraction at the initial, two-week and one-month visits.

5 secondary outcomes

Subjective Scores
Time frame: 1 month
Symptoms, problems and complaints
Time frame: 1 month
Discontinuations
Time frame: 1 month
Refraction
Time frame: 1 month
Keratometry
Time frame: 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
Results publication: PubMed 23892493Varikooty J, Keir N, Richter D, Jones LW, Woods C, Fonn D. Comfort response of three silicone hydrogel daily disposable contact lenses. Optom Vis Sci. 2013 Sep;90(9):945-53. doi: 10.1097/OPX.0b013e31829d8dbf.
Results publication: PubMed 23770656Belda-Salmeron L, Ferrer-Blasco T, Albarran-Diego C, Madrid-Costa D, Montes-Mico R. Diurnal variations in visual performance for disposable contact lenses. Optom Vis Sci. 2013 Jul;90(7):682-90. doi: 10.1097/OPX.0b013e318299088f.
Results publication: PubMed 23510388Montes-Mico R, Belda-Salmeron L, Ferrer-Blasco T, Albarran-Diego C, Garcia-Lazaro S. On-eye optical quality of daily disposable contact lenses for different wearing times. Ophthalmic Physiol Opt. 2013 Sep;33(5):581-91. doi: 10.1111/opo.12044. Epub 2013 Mar 19.
Clinical Study of Clariti Monthly Contact LensLink provided by the sponsor.

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Recruiting
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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
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Recruiting
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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.

Philip Morgan, PhD principal investigator

MCOptom FAAO FBCLA

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

Questions about this trial

What is this clinical trial studying?

A study testing Air Optix Aqua and Clariti with Handling Tint in people with Hyperopia and Myopia, run by Sauflon Pharmaceuticals Ltd 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 9 inclusion and 14 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 27 Nov 2013. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Slit lamp Biomicroscopy (time frame: 1 month). 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 NCT01996787, which also lists 3 linked publications.

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 27 Nov 2013.