PresbyopiaNCT03757039

Multifocal Visual Performance Study

A study testing Multifocal soft contact lenses and Progressive addition lens spectacles in people with Presbyopia, run by Alcon Research at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this trial was to compare the functional visual performance of Precision Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a presbyopic population. Read more about this study

Who is it for?: Ages 38 to 58 years
Conditions the study is for: Presbyopia
What is being tested?: Multifocal soft contact lenses and Progressive addition lens spectacles
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 2 sitesin 2 countries
Study dates: 16 Dec 2018to 6 Mar 2019
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 38 to 58 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Normal eyes, other than correction for refractive error;
Habitual correction of either any multifocal contact lens with a maximum add of +2.00 Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00 D;
Wears habitual correction at least 5 days per week and at least 6 hours per day.

Who cannot join

Monocular subjects;
Subjects fit with only one contact lens;
Known pregnancy or lactating;
History of or planned refractive surgery or irregular cornea in either eye.
Other protocol-specified inclusion and/or exclusion criteria may apply.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Alcon Investigative Site
Houston, Texas, 77204-2020

Other trials in United States

United Kingdom1 site

Alcon Investigative Site
Birmingham, B4 7ET

Other trials in United Kingdom

About this study

Official title: Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses

Read the detailed description

Habitual contact lens wearers were randomized 1:1:1 to one of three commercially available multifocal contact lenses. Progressive addition lens wearers wore their habitual spectacles. Subjects were expected to attend 1 or 2 office visits. This study was terminated early by Alcon due to slow enrollment and inconsistency in measurement of the primary endpoint.

Conditions: Presbyopia
Being tested: Multifocal soft contact lenses, Progressive addition lens spectacles
Keywords: contact lenses, multifocal, spectacles, glasses, progressive, vision, eyes
Medical subject headings: Presbyopia

What participants receive

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

Multifocal soft contact lensesDevice
Also called DAILIES TOTAL1® Multifocal contact lenses (DT1 MF), DAILIES® AquaComfort Plus® Multifocal contact lenses (DACP MF), AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF)
Commercially available contact lenses
Progressive addition lens spectaclesOther
Also called PAL
Per subject's habitual prescription

Study groups in NCT03757039
Study group	Role	What they receive
Multifocal Contact Lenses	Experimental	Multifocal soft contact lenses according to the subject's prescription and fitted using the Alcon multifocal fitting guide. Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only. Receives: Device: Multifocal soft contact lenses
PAL Spectacles	Active comparator	Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only. Receives: Other: Progressive addition lens spectacles

What is being measured

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

Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)
The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.
Measured: Day 1, after up to 3 hours of wear

Timeline

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

16 Dec 20186 Mar 2019

First posted28 Nov 2018
Study start16 Dec 2018
Primary completion6 Mar 2019
Study completion6 Mar 2019

Why it stopped: Management Decision

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 PresbyopiaStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03757039
Sponsor's protocol ID: CLT792-P001
Status last verified: Mar 2020
First submitted: 27 Nov 2018
Last updated: 25 Mar 2020
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

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia

All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
ClinicalTrials.gov ID: NCT03757039
Acronym / sponsor ID: CLT792-P001
Conditions: Presbyopia
Keywords: contact lenses, multifocal, spectacles, glasses, progressive, vision, eyes
Study type: Interventional
Recruitment status: TerminatedReason stopped: Management Decision
Enrolment: 42 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 16 Dec 2018 (actual)
Primary completion: 6 Mar 2019 (actual)
Study completion: 6 Mar 2019 (actual)
First posted: 28 Nov 2018 (actual)
Results: Posted 25 Mar 2020

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Multifocal Contact Lenses	Experimental	Device: Multifocal soft contact lensesMultifocal soft contact lenses according to the subject's prescription and fitted using the Alcon multifocal fitting guide. Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only.
PAL Spectacles	Active comparator	Other: Progressive addition lens spectaclesProgressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.

Who may qualify

Ages: 38 to 58 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Normal eyes, other than correction for refractive error;
Habitual correction of either any multifocal contact lens with a maximum add of +2.00 Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00 D;
Wears habitual correction at least 5 days per week and at least 6 hours per day.

Key exclusion criteria (5 listed)

Monocular subjects;
Subjects fit with only one contact lens;
Known pregnancy or lactating;
History of or planned refractive surgery or irregular cornea in either eye.
Other protocol-specified inclusion and/or exclusion criteria may apply.

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
Multifocal soft contact lensesAlso: DAILIES TOTAL1® Multifocal contact lenses (DT1 MF), DAILIES® AquaComfort Plus® Multifocal contact lenses (DACP MF), AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF)Commercially available contact lenses	Device	Multifocal Contact Lenses
Progressive addition lens spectaclesAlso: PALPer subject's habitual prescription	Other	PAL Spectacles

Primary outcome

Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)
Time frame: Day 1, after up to 3 hours of wear
The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.

Results and safety

Results posted to the registry on 25 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multifocal Contact Lenses	32	32
PAL Spectacles Wearers	9	9

Primary outcome: Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)

Time frame: Day 1, after up to 3 hours of wear. Mean (Standard Deviation). Unit: seconds

Measure	Multifocal Contact Lenses n = 32	PAL Spectacles n = 9
Value	2.602 (1.136)	2.774 (0.839)

Population analysed: This analysis population includes all subjects assigned to PALs or randomized to the contact lens group who were exposed to any study product evaluated in this study, except for the lenses used for optimization and fitting (Full Analysis Set).

Adverse events

Time frame: Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AOHG MF	0 of 11 (0%)	0 of 11 (0%)	0 of 11
DT1 MF	0 of 11 (0%)	0 of 11 (0%)	0 of 11
DACP MF	0 of 10 (0%)	0 of 10 (0%)	0 of 10
PALs	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9

Limitations and caveats (from the sponsor): Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia

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.

Senior Clinical Manager, CDMA study director

Alcon Research, LLC

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multifocal soft contact lenses and Progressive addition lens spectacles in people with Presbyopia, run by Alcon Research at 2 sites in 2 countries.

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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, 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?

Yes. Results are posted in the registry (first posted 25 Mar 2020). 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?

Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set) (time frame: Day 1, after up to 3 hours of wear). 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 NCT03757039.

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 25 Mar 2020.