AstigmatismNCT03578926

Performance of Two Toric Silicone Hydrogel Contact Lenses

A study testing fanfilcon A toric lens and senofilcon A 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

Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear. 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 senofilcon A toric lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteMexico
Study dates: 18 Jun 2018to 8 Oct 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

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
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

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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

Official title: Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear

Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.

Read the detailed description

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.

Conditions: Astigmatism
Being tested: fanfilcon A toric lens, senofilcon A 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
senofilcon A toric lensDevice
Also called Acuvue Oasys for Astigmatism
contact lens

Study groups in NCT03578926
Study group	Role	What they receive
fanfilcon A toric lens	Experimental	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. Receives: Device: fanfilcon A toric lens
senofilcon A toric lens	Active comparator	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. Receives: Device: senofilcon A 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 (Optimum, Decentration acceptable, Decentration unacceptable)
Measured: Baseline
Lens Centration
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Measured: 2 weeks
Corneal Coverage
Lens covering the cornea (Yes, No)
Measured: Baseline
Corneal Coverage
Lens covering the cornea (Yes, No)
Measured: 2 weeks
Post Blink Movement
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Measured: Baseline
Post Blink Movement
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Measured: 2 weeks

Secondary outcomes (2)

Wearing Time
Average daily wearing time (hours/day)
Measured: 2 weeks
Comfortable Wearing Time
Comfortable daily wearing time (hours/day)
Measured: 2 weeks

Timeline

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

18 Jun 20188 Oct 2018

First posted6 Jul 2018
Study start18 Jun 2018
Primary completion8 Oct 2018
Study completion8 Oct 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
Model description: Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03578926
Sponsor's protocol ID: EX-MKTG-93
Status last verified: Nov 2019
First submitted: 25 Jun 2018
Last updated: 10 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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

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 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear
ClinicalTrials.gov ID: NCT03578926
Acronym / sponsor ID: EX-MKTG-93
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 18 Jun 2018 (actual)
Primary completion: 8 Oct 2018 (actual)
Study completion: 8 Oct 2018 (actual)
First posted: 6 Jul 2018 (actual)
Results: Posted 10 Dec 2019

Clinical summary

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

Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.

Detailed description

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.

Arm	Type	Receives
fanfilcon A toric lens	Experimental	Device: fanfilcon A toric lensRandomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.
senofilcon A toric lens	Active comparator	Device: senofilcon A toric lensRandomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.

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 (20 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 lens
senofilcon A toric lensAlso: Acuvue Oasys for Astigmatismcontact lens	Device	senofilcon A toric lens

Primary outcome

Lens Centration
Time frame: Baseline
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Lens Centration
Time frame: 2 weeks
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Corneal Coverage
Time frame: Baseline
Lens covering the cornea (Yes, No)
Corneal Coverage
Time frame: 2 weeks
Lens covering the cornea (Yes, No)
Post Blink Movement
Time frame: Baseline
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Post Blink Movement
Time frame: 2 weeks
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

2 secondary outcomes

Wearing Time
Time frame: 2 weeks
Comfortable Wearing Time
Time frame: 2 weeks

Results and safety

Results posted to the registry on 10 Dec 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	21	21
Senofilcon A Toric	23	23

Primary outcome: Lens Centration

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

Measure	Fanfilcon A n = 44	Senofilcon A n = 44
Value	44	44

Primary outcome: Lens Centration

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Fanfilcon A n = 44	Senofilcon A n = 44
Optimal Centration	44	44
Decentration Acceptable	0	0
Decentration unacceptable	0	0

Primary outcome: Corneal Coverage

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

Measure	Fanfilcon A n = 44	Senofilcon A n = 44
Yes	44	44
No	0	0

Primary outcome: Corneal Coverage

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Fanfilcon A n = 44	Senofilcon A n = 44
Yes	44	44
No	0	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 weeks during each crossover period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fanfilcon A	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Senofilcon A	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

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.

Ruben Velázquez Guerrero, MSc., FIACLE principal investigator

School of Optometry, National Autonomous University

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 senofilcon A 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 20 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 10 Dec 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 10 Dec 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 6 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 NCT03578926.

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 10 Dec 2019.