Refractive ErrorNCT02694835

Initial Performance of a Modified Daily Disposable Contact Lens

A study testing Delefilcon A contact lenses with UV Absorber and Delefilcon A contact lenses in people with Refractive Error, run by Alcon Research.

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 is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error
What is being tested?: Delefilcon A contact lenses with UV Absorber and Delefilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: No sites listed yet
Study dates: 21 Mar 2016to 11 Apr 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must sign an Informed Consent document;
Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
Manifest astigmatism less than or equal to 0.75 D (at screening);
Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
Other protocol-specified inclusion criteria may apply.

Who cannot join

Eye injury in either eye within 12 weeks prior to study enrollment;
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
History of herpetic keratitis;
History of refractive surgery or irregular cornea;
Pathologically dry eye that precludes contact lens wear;

Show all 9Show fewer

Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
Monocular (only 1 eye with functional vision);
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens

Conditions: Refractive Error
Being tested: Delefilcon A contact lenses with UV Absorber, Delefilcon A contact lenses
Medical subject headings: Refractive Errors

What participants receive

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

Delefilcon A contact lenses with UV AbsorberDevice
Also called DAILIES TOTAL1® UV (DT1 UV)
Delefilcon A contact lensesDevice
Also called DAILIES TOTAL1® (DT1)

Study groups in NCT02694835
Study group	Role	What they receive
DT1 UV	Experimental	Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours Receives: Device: Delefilcon A contact lenses with UV Absorber
DT1	Active comparator	Delefilcon A contact lenses worn bilaterally for 9 hours Receives: Device: Delefilcon A contact lenses

What is being measured

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

Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.
Measured: Day 1 at Hour 9 ± 3 hours

Timeline

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

21 Mar 201611 Apr 2016

First posted1 Mar 2016 (estimated)
Study start21 Mar 2016
Primary completion11 Apr 2016
Study completion11 Apr 2016

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 Refractive ErrorStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02694835
Sponsor's protocol ID: CLP691-C001
Status last verified: Feb 2019
First submitted: 12 Feb 2016
Last updated: 13 Mar 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?

Official record

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
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Refractive Error trials

Study at a glance

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

Official title: Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens
ClinicalTrials.gov ID: NCT02694835
Acronym / sponsor ID: CLP691-C001
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 21 Mar 2016 (actual)
Primary completion: 11 Apr 2016 (actual)
Study completion: 11 Apr 2016 (actual)
First posted: 1 Mar 2016 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DT1 UV	Experimental	Device: Delefilcon A contact lenses with UV AbsorberDelefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
DT1	Active comparator	Device: Delefilcon A contact lensesDelefilcon A contact lenses worn bilaterally for 9 hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Must sign an Informed Consent document;
Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
Manifest astigmatism less than or equal to 0.75 D (at screening);
Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);

Key exclusion criteria (9 listed)

Eye injury in either eye within 12 weeks prior to study enrollment;
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
History of herpetic keratitis;
History of refractive surgery or irregular cornea;

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
Delefilcon A contact lenses with UV AbsorberAlso: DAILIES TOTAL1® UV (DT1 UV)	Device	DT1 UV
Delefilcon A contact lensesAlso: DAILIES TOTAL1® (DT1)	Device	DT1

Primary outcome

Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
Time frame: Day 1 at Hour 9 ± 3 hours
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.

Results and safety

Results posted to the registry on 15 Feb 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
DT1 UV	41	41
Dailies Total1 (DT1)	39	39

Primary outcome: Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)

Time frame: Day 1 at Hour 9 ± 3 hours. Count of units. Unit: Eyes

Measure	DT1 UV n = 41	Dailies Total1 (DT1) n = 39
Value	0	0

Population analysed: Full Analysis Set

Adverse events

Time frame: Duration of enrollment = 1 Day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DT1 UV	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Dailies Total1 (DT1)	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Refractive Error

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
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
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.

Clinical Manager, GCRA study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A contact lenses with UV Absorber and Delefilcon A contact lenses in people with Refractive Error, run by Alcon Research.

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 6 inclusion and 9 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

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 Feb 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?

Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) (time frame: Day 1 at Hour 9 ± 3 hours). 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 NCT02694835.

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 Mar 2019.