Refractive ErrorsNCT03034928

Clinical Biocompatibility Evaluation of Contact Lens Coatings

A study testing Contact lens with investigational coating 1, Balafilcon A contact lens and OPTI-FREE® RepleniSH® MPDS in people with Refractive Errors and Ametropia, run by Alcon Research at 1 site in United States.

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 primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Errors, Ametropia
What is being tested?: Contact lens with investigational coating 1, Balafilcon A contact lens and OPTI-FREE® RepleniSH® MPDS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2017to 14 Mar 2017
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

Able to understand and must sign an Informed Consent;
Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;
Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
Current or history of pathologically dry eye in either eye that would preclude contact lens wear;
Current or history of herpetic keratitis in either eye;

Show all 11Show fewer

Eye injury in either eye within 12 weeks immediately prior to enrollment;
History of intolerance or hypersensitivity to any component of the study lenses or solutions;
Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Alcon Investigative Site
Johns Creek, Georgia, 30097

Other trials in United States

About this study

Read the detailed description

In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Conditions: Refractive Errors, Ametropia
Being tested: Contact lens with investigational coating 1, Balafilcon A contact lens, OPTI-FREE® RepleniSH® MPDS, Contact lens with investigational coating 2
Medical subject headings: Refractive Errors

What participants receive

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

Contact lens with investigational coating 1Device
Also called Test 1
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lensDevice
Also called Bausch & Lomb PureVision™, Control 1, Control 2
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
OPTI-FREE® RepleniSH® MPDSDevice
Multipurpose contact lens solution
Contact lens with investigational coating 2Device
Also called Test 2
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS

Study groups in NCT03034928
Study group	Role	What they receive
Test 1/Control 1, then Control 2/Test 2	Other	Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. Receives: Device: Contact lens with investigational coating 1; Device: Balafilcon A contact lens; Device: OPTI-FREE® RepleniSH® MPDS; Device: Contact lens with investigational coating 2
Test 2/Control 2, then Control 1/Test 1	Other	Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. Receives: Device: Contact lens with investigational coating 1; Device: Balafilcon A contact lens; Device: OPTI-FREE® RepleniSH® MPDS; Device: Contact lens with investigational coating 2
Control 1/Test 1, then Test 2/Control 2	Other	Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. Receives: Device: Contact lens with investigational coating 1; Device: Balafilcon A contact lens; Device: OPTI-FREE® RepleniSH® MPDS; Device: Contact lens with investigational coating 2
Control 2/Test 2, then Test 1/Control 1	Other	Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. Receives: Device: Contact lens with investigational coating 1; Device: Balafilcon A contact lens; Device: OPTI-FREE® RepleniSH® MPDS; Device: Contact lens with investigational coating 2

What is being measured

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

Average Percent Area of Solution-related Corneal Staining
Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.
Measured: Day 1 after 2 hours of wear, each product

Timeline

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

14 Feb 201714 Mar 2017

First posted27 Jan 2017 (estimated)
Study start14 Feb 2017
Primary completion14 Mar 2017
Study completion14 Mar 2017

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 ErrorsStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03034928
Sponsor's protocol ID: CLY935-E002
Status last verified: Feb 2020
First submitted: 25 Jan 2017
Last updated: 18 Feb 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

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All Refractive Errors trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Biocompatibility Evaluation of Contact Lens Coatings
ClinicalTrials.gov ID: NCT03034928
Acronym / sponsor ID: CLY935-E002
Conditions: Refractive Errors, Ametropia
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 14 Feb 2017 (actual)
Primary completion: 14 Mar 2017 (actual)
Study completion: 14 Mar 2017 (actual)
First posted: 27 Jan 2017 (estimated)
Results: Posted 18 Feb 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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Test 1/Control 1, then Control 2/Test 2	Other	Device: Contact lens with investigational coating 1, Device: Balafilcon A contact lens, Device: OPTI-FREE® RepleniSH® MPDS, Device: Contact lens with investigational coating 2Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Test 2/Control 2, then Control 1/Test 1	Other	Device: Contact lens with investigational coating 1, Device: Balafilcon A contact lens, Device: OPTI-FREE® RepleniSH® MPDS, Device: Contact lens with investigational coating 2Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Control 1/Test 1, then Test 2/Control 2	Other	Device: Contact lens with investigational coating 1, Device: Balafilcon A contact lens, Device: OPTI-FREE® RepleniSH® MPDS, Device: Contact lens with investigational coating 2Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Control 2/Test 2, then Test 1/Control 1	Other	Device: Contact lens with investigational coating 1, Device: Balafilcon A contact lens, Device: OPTI-FREE® RepleniSH® MPDS, Device: Contact lens with investigational coating 2Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.

Who may qualify

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

Key inclusion criteria (6 listed)

Able to understand and must sign an Informed Consent;
Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;
Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;

Key exclusion criteria (11 listed)

Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
Current or history of pathologically dry eye in either eye that would preclude contact lens wear;

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
Contact lens with investigational coating 1Also: Test 1Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)	Device	Control 1/Test 1, then Test 2/Control 2, Control 2/Test 2, then Test 1/Control 1, Test 1/Control 1, then Control 2/Test 2, Test 2/Control 2, then Control 1/Test 1
Balafilcon A contact lensAlso: Bausch & Lomb PureVision™, Control 1, Control 2Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS	Device	Control 1/Test 1, then Test 2/Control 2, Control 2/Test 2, then Test 1/Control 1, Test 1/Control 1, then Control 2/Test 2, Test 2/Control 2, then Control 1/Test 1
OPTI-FREE® RepleniSH® MPDSMultipurpose contact lens solution	Device	Control 1/Test 1, then Test 2/Control 2, Control 2/Test 2, then Test 1/Control 1, Test 1/Control 1, then Control 2/Test 2, Test 2/Control 2, then Control 1/Test 1
Contact lens with investigational coating 2Also: Test 2Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS	Device	Control 1/Test 1, then Test 2/Control 2, Control 2/Test 2, then Test 1/Control 1, Test 1/Control 1, then Control 2/Test 2, Test 2/Control 2, then Control 1/Test 1

Primary outcome

Average Percent Area of Solution-related Corneal Staining
Time frame: Day 1 after 2 hours of wear, each product
Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.

Results and safety

Results posted to the registry on 18 Feb 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
Test 1/Control 1, Then Control 2/Test 2	8	8
Test 2/Control 2, Then Control 1/Test 1	8	8
Control 1/Test 1, Then Test 2/Control 2	9	9
Control 2/Test 2, Then Test 1/Control 1	8	8

Primary outcome: Average Percent Area of Solution-related Corneal Staining

Time frame: Day 1 after 2 hours of wear, each product. Mean (Standard Deviation). Unit: percentage of area

Measure	Test 1 n = 33	Control 1 n = 33	Test 2 n = 33	Control 2 n = 33
Value	7.01 (10.54)	12.82 (17.93)	13.54 (17.20)	7.58 (10.34)

Population analysed: This analysis population includes all randomized subjects who satisfied protocol-specified criteria (Full Analysis Set).

Adverse events

Time frame: Baseline through study completion, approximately 8 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test 1	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Test 2	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Control	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Sr. Clinical Manager, Trial Management Operations study director

Alcon, A Novartis Division

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

Questions about this trial

What is this clinical trial studying?

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 11 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 18 Feb 2020. 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 United States. 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 18 Feb 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 Percent Area of Solution-related Corneal Staining (time frame: Day 1 after 2 hours of wear, each product). 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 NCT03034928.

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 18 Feb 2020.