CompletedNCT02965820Updated Jul 12, 2018Results posted

OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

An interventional study of Opti-Free® PureMoist® contact lens solution and Habitual Multi-Purpose Contact Lens Solution in Presbyopia, sponsored by Alcon, a Novartis Company. Completed. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-12.

Sponsored by Alcon, a Novartis Company (formerly part of Novartis) · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 122
Allocation: Randomized
Ages: 45 Years to 65 Years
Sex: All

Study summary

The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.

Conditions studied

Presbyopia

Browse trials for

Presbyopia 336

Keywords

Contact lens induced dryness

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 122 is above the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Alcon, a Novartis Company is the lead sponsor of 13 studies on the registry; none are open to participants now.

First submitted before Alcon left Novartis.

Browse Alcon studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Must sign an document;
Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
Near spectacle add of +0.50 or greater;
Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
Currently using a non-Alcon multi-purpose solution to care for lenses (at least 2 months);
Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
Other protocol-specific inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
Any use of systemic or ocular medications for which contact lens wear could be , as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Known sensitivity to any ingredients in OFPM;
Prior refractive surgery;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Pathological dry eye that precludes contact lens wear;
Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
Participation in any clinical study within 30 days of Visit 1;
Currently using or have not discontinued Restasis®, Xiidra® or a topical within the past 7 days;
Other protocol-specific exclusion criteria may apply.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 122 participants (actual)

Study arms

Other
OFPM, then HMPS
OPTI-FREE® PureMoist® multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Device: Opti-Free® PureMoist® contact lens solution · Device: Habitual Multi-Purpose Contact Lens Solution · Device: Habitual Contact Lenses
Other
HMPS, then OFPM
Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Device: Opti-Free® PureMoist® contact lens solution · Device: Habitual Multi-Purpose Contact Lens Solution · Device: Habitual Contact Lenses

Interventions

DeviceOpti-Free® PureMoist® contact lens solution
Also known as: OPTI-FREE® PureMoist®
DeviceHabitual Multi-Purpose Contact Lens Solution
DeviceHabitual Contact Lenses
Subject's habitual contact lens brand worn in a daily wear modality for 30 days.

What researchers measure

Primary outcomes

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
Time frame: Day 30, each product

Results

Posted Apr 26, 2018

Participant flow

Subjects were recruited from 8 study centers located in the United States.

Period 1, First 30 Days

Participant flow — Period 1, First 30 Days
Milestone	OFPM/HMPS	HMPS/OFPM
Started	59	62
Completed	59	62
Not completed	0	0

Period 2, Second 30 Days

Participant flow — Period 2, Second 30 Days
Milestone	OFPM/HMPS	HMPS/OFPM
Started	58	62
Completed	57	61
Not completed	1	1
Withdrew: Adverse event	1	1

Outcome measures

PrimaryContact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30

CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.

Time frame:: Day 30, each product
Reported as:: Mean · units on a scale

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
units on a scale	OFPM	HMPS
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30	13.4 ± 7.42	15.8 ± 7.87

Statistical analysis

OFPM vs HMPS · Mixed Models Analysis · p = =0.0030

Adverse events

Collected over Day 1 through study completion, an average of 60 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OFPM	0/121 (0%)	1/121 (0.8%)	0/121 (0%)
HMPS	0/120 (0%)	0/120 (0%)	0/120 (0%)

Most frequent serious events

Most frequent serious events
Event	OFPM	HMPS
Knee operationSurgical and medical procedures	1/121	0/120

Baseline characteristics

This analysis population includes all subjects exposed to study lens care products (Full Analysis Set).

Age, Continuous
Age, Continuous(years)	Overall
Mean	52.7 ± 5.32

Sex: Female, Male
Sex: Female, Male(Participants)	Overall
Female	92
Male	29

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Overall
Hispanic or Latino	2
Not Hispanic or Latino	119
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Overall
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	20
White	101
More than one race	0
Unknown or Not Reported	0

Study locations

No study locations are listed for this record.

References and documents

Study documents

Study protocol ↗ · Jan 3, 2017
Statistical analysis plan ↗ · Dec 11, 2016

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2016 to primary completion in Apr 2017, 3 months.

Results were first posted in Apr 2018, 1 year after primary completion.

Of 87 industry-sponsored interventional studies with no phase under Presbyopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's 3 months is below that.

Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 15, 2016
First posted: Nov 17, 2016
StartActual: Dec 16, 2016
Primary completionActual: Apr 1, 2017
CompletionActual: Apr 1, 2017
Results first posted: Apr 26, 2018
Last update: Jul 12, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02965820
Lead sponsor: Alcon, a Novartis Company
Responsible party: Sponsor
First posted: Nov 17, 2016
Start date: Dec 16, 2016
Primary completion: Apr 1, 2017
Completion: Apr 1, 2017
Results posted: Apr 26, 2018
Last update: Jul 12, 2018

Study contacts

Clinical Project Manager, CPM

study director · Alcon, A Novartis Division

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Presbyopia →

Other studies from this sponsor

Alcon, a Novartis Company →

Start the discussion