AstigmatismNCT03418064

Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

A study testing Fanfilcon A toric lens and Lotrafilcon B toric lens in people with Astigmatism, run by CooperVision, Inc. at 1 site in Mexico.

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 aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Astigmatism
What is being tested?: Fanfilcon A toric lens and Lotrafilcon B toric lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteMexico
Study dates: 10 Feb 2018to 16 May 2018
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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted soft contact lens wearer
Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

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Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Patient contact lens refraction should fit within the available parameters of the study lenses.
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule

Who cannot join

A person will be excluded from the study if he/she:
Has a CL prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities

Show all 21Show fewer

Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings
Pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (past or present)
Seborrheic eczema, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Optometry Clinic, National Autonomous University
Mexico City

Other trials in Mexico

About this study

The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.

Read the detailed description

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.

Conditions: Astigmatism
Being tested: Fanfilcon A toric lens, Lotrafilcon B toric lens
Medical subject headings: Astigmatism

What participants receive

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

Fanfilcon A toric lensDevice
Also called Avaira Vitality toric lens
Contact lens
Lotrafilcon B toric lensDevice
Also called AIR OPTIX for Astigmatism
Contact lens

Study groups in NCT03418064
Study group	Role	What they receive
fanfilcon A toric	Experimental	Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study. Receives: Device: Fanfilcon A toric lens
lotrafilcon B	Active comparator	Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study. Receives: Device: Lotrafilcon B toric lens

What is being measured

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

Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Measured: Baseline
Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Measured: Dispense
Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Measured: 1 Month
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Measured: Baseline
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Measured: Dispense
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Measured: 1 Month
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Measured: Baseline
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Measured: Dispense
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Measured: 1 Month
Overall Fit Acceptance
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
Measured: Dispense
Overall Fit Acceptance
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
Measured: 1 Month

Secondary outcomes (4)

Average Hours of Wear Per Day
Number of hours lenses are worn per day
Measured: Baseline
Average Hours of Wear Per Day
Number of hours lenses are worn per day
Measured: 1 month
Average Comfortable Wearing Time
Typical time of day when subject first experiences lens awareness or irritation.
Measured: Baseline
Average Comfortable Wearing Time
Typical time of day when subject first experiences lens awareness or irritation
Measured: 1 Month

Timeline

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

10 Feb 201816 May 2018

First posted1 Feb 2018
Study start10 Feb 2018
Primary completion16 May 2018
Study completion16 May 2018

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 AstigmatismStudies 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: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03418064
Sponsor's protocol ID: EX-MKTG-90
Status last verified: Oct 2019
First submitted: 25 Jan 2018
Last updated: 13 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

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

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear
ClinicalTrials.gov ID: NCT03418064
Acronym / sponsor ID: EX-MKTG-90
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 10 Feb 2018 (actual)
Primary completion: 16 May 2018 (actual)
Study completion: 16 May 2018 (actual)
First posted: 1 Feb 2018 (actual)
Results: Posted 13 Nov 2019

Clinical summary

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

The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.

Detailed description

Study design

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

Arm	Type	Receives
fanfilcon A toric	Experimental	Device: Fanfilcon A toric lensSubjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study.
lotrafilcon B	Active comparator	Device: Lotrafilcon B toric lensSubjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted soft contact lens wearer
Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.

Key exclusion criteria (21 listed)

Has a CL prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities

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
Fanfilcon A toric lensAlso: Avaira Vitality toric lensContact lens	Device	fanfilcon A toric
Lotrafilcon B toric lensAlso: AIR OPTIX for AstigmatismContact lens	Device	lotrafilcon B

Primary outcome

Lens Centration
Time frame: Baseline
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Lens Centration
Time frame: Dispense
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Lens Centration
Time frame: 1 Month
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Corneal Coverage
Time frame: Baseline
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Corneal Coverage
Time frame: Dispense
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Corneal Coverage
Time frame: 1 Month
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Post-blink Movement
Time frame: Baseline
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Post-blink Movement
Time frame: Dispense
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Post-blink Movement
Time frame: 1 Month
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Overall Fit Acceptance
Time frame: Dispense
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
Overall Fit Acceptance
Time frame: 1 Month
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)

4 secondary outcomes

Average Hours of Wear Per Day
Time frame: Baseline
Average Hours of Wear Per Day
Time frame: 1 month
Average Comfortable Wearing Time
Time frame: Baseline
Average Comfortable Wearing Time
Time frame: 1 Month

Results and safety

Results posted to the registry on 13 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fanfilcon A Toric, Then Lotrafilcon B Toric	21	21
Lotrafilcon B Toric, Then Fanfilcon A Toric	21	21

Primary outcome: Lens Centration

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Habitual Toric Lens at Baseline n = 42
1-Optimal Centration	41
2-Decentration acceptable	1
3-Decentranation Unacceptable	0

Primary outcome: Lens Centration

Time frame: Dispense. Count of participants. Unit: Participants

Measure	Fanfilcon A Toric at Dispense n = 42	Lotrafilcon B Toric at Dispense n = 42
1-Optimal Centration	42	42
2-Decentration acceptable	0	0
3-Decentranation Unacceptable	0	0

Primary outcome: Lens Centration

Time frame: 1 Month. Count of participants. Unit: Participants

Measure	Fanfilcon A Toric Lens at 1 Month n = 42	Lotrafilcon B Toric at 1 Month n = 42
1-Optimal Centration	42	42
2-Decentration acceptable	0	0
3-Decentranation Unacceptable	0	0

Primary outcome: Corneal Coverage

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Habitual Toric Lens at Baseline n = 42
Full Coverage (Yes)	42
Incomplete (No)	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense to completion of follow up, up to 1 month.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fanfilcon A Toric	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Lotrafilcon B Toric	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
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Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Recruiting
Clareon TruPlus Study
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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Fanfilcon A toric lens and Lotrafilcon B toric lens in people with Astigmatism, run by CooperVision, Inc. at 1 site in Mexico.

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 12 inclusion and 21 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 13 Nov 2019. 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 Mexico. 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 13 Nov 2019). 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?

Lens Centration (time frame: Baseline). The study lists 11 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 NCT03418064.

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 13 Nov 2019.