Tear Film CharacteristicsPhase 4GAMBIANCT06966349

Quantifying Ocular Surface Aberrations After Tear Film Interventions

A Phase 4 study testing Systane Complete Preservative-Free, Senofilcon A and Somofilcon A in people with Tear Film Characteristics, run by University of Waterloo at 1 site in Canada.

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 CA-800 Corneal Analyzer (Visia Imaging S.R.L., Italy) is a device that can measure small imperfections in the tear film when the eyes are open. The goal of this study is to see if the device can detect changes in the tear film after instillation of an eye drop or when contact lenses are worn. Read more about this study

Who is it for?: Ages 17 years and olderHealthy volunteers can take part
Conditions the study is for: Tear Film Characteristics
What is being tested?: Systane Complete Preservative-Free, Senofilcon A and Somofilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteCanada
Study dates: 10 Jun 2025to 29 Jan 2026
Phase: Phase 4
Are there results?: None posted in the registry

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 17 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Are at least 17 years of age and have full legal capacity to volunteer.
Have signed the information consent letter.
Are willing and able to follow instructions and maintain the appointment schedule.
Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear).
Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye.
Achieve a best corrected visual acuity of 0.00 logMAR or better in each eye.

Show all 9Show fewer

Agree to wear the study contact lenses for at least 6 hours.
Have clear corneas (e.g. no central scars).
Have no active ocular disease or inflammation.

Who cannot join

Are participating in another concurrent clinical research study.
Have worn any rigid contact lenses in the past 30 days.
Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
Have any known active ocular condition, disease, and/or infection.*
Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.
Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study.
Have undergone refractive error surgery.
Are a member of the study team for this study, i.e. are listed on the delegation log for this study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Ocular Research & Education
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Conditions: Tear Film Characteristics
Being tested: Systane Complete Preservative-Free, Senofilcon A, Somofilcon A

What participants receive

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

Systane Complete Preservative-FreeDrug
One drop of Systane Complete Preservative Free will be instilled in each eye.
Higher order aberrations assessed before and after instillation.
Senofilcon ADevice
Also called ACUVUE OASYS MAX 1-Day
Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia.
Higher order aberrations assessed before and after instillation.
Somofilcon ADevice
Also called clariti 1 day
Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia.
Higher order aberrations assessed before and after instillation.

Study groups in NCT06966349
Study group	Role	What they receive
Experimental: Systane Complete / Senofilcon A/ Somofilcon A	Experimental	On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes. Receives: Drug: Systane Complete Preservative-Free; Device: Senofilcon A; Device: Somofilcon A
Experimental: Systane Complete/ Somofilcon A/ Senofilcon A	Experimental	On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes. Receives: Drug: Systane Complete Preservative-Free; Device: Senofilcon A; Device: Somofilcon A

What is being measured

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

Change in higher order aberrations with an eye drop
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Measured: Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop
Change in higher order aberrations with senofilcon A
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Measured: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
Change in higher order aberrations with somofilcon A
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Measured: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens

Timeline

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

10 Jun 202529 Jan 2026

First posted11 May 2025
Study start10 Jun 2025
Primary completion29 Jan 2026
Study completion29 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tear Film CharacteristicsStudies 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06966349
Sponsor's protocol ID: 47100
Acronym: GAMBIA
Status last verified: Mar 2026
First submitted: 2 May 2025
Last updated: 24 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quantifying Ocular Surface Aberrations After Tear Film Interventions
ClinicalTrials.gov ID: NCT06966349
Acronym / sponsor ID: GAMBIA / 47100
Conditions: Tear Film Characteristics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Study start: 10 Jun 2025 (actual)
Primary completion: 29 Jan 2026 (actual)
Study completion: 29 Jan 2026 (actual)
First posted: 11 May 2025 (actual)
Results: Not posted in the source record

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Experimental: Systane Complete / Senofilcon A/ Somofilcon A	Experimental	Drug: Systane Complete Preservative-Free, Device: Senofilcon A, Device: Somofilcon AOn the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes.
Experimental: Systane Complete/ Somofilcon A/ Senofilcon A	Experimental	Drug: Systane Complete Preservative-Free, Device: Senofilcon A, Device: Somofilcon AOn the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes.

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Are at least 17 years of age and have full legal capacity to volunteer.
Have signed the information consent letter.
Are willing and able to follow instructions and maintain the appointment schedule.
Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear).
Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye.

Key exclusion criteria (8 listed)

Are participating in another concurrent clinical research study.
Have worn any rigid contact lenses in the past 30 days.
Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
Have any known active ocular condition, disease, and/or infection.*
Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.

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
Systane Complete Preservative-FreeOne drop of Systane Complete Preservative Free will be instilled in each eye. Higher order aberrations assessed before and after instillation.	Drug	Experimental: Systane Complete / Senofilcon A/ Somofilcon A, Experimental: Systane Complete/ Somofilcon A/ Senofilcon A
Senofilcon AAlso: ACUVUE OASYS MAX 1-DayDaily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.	Device	Experimental: Systane Complete / Senofilcon A/ Somofilcon A, Experimental: Systane Complete/ Somofilcon A/ Senofilcon A
Somofilcon AAlso: clariti 1 dayDaily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.	Device	Experimental: Systane Complete / Senofilcon A/ Somofilcon A, Experimental: Systane Complete/ Somofilcon A/ Senofilcon A

Primary outcome

Change in higher order aberrations with an eye drop
Time frame: Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Change in higher order aberrations with senofilcon A
Time frame: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Change in higher order aberrations with somofilcon A
Time frame: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Individual participant dataSharing planned: No

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.

Lyndon Jones, PhD, DSc, FCOptom principal investigator

Centre for Ocular Research & Education

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Systane Complete Preservative-Free, Senofilcon A and Somofilcon A in people with Tear Film Characteristics, run by University of Waterloo at 1 site in Canada.

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 9 inclusion and 8 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 24 Apr 2026. 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 Canada. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in higher order aberrations with an eye drop (time frame: Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop). The study lists 3 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 NCT06966349.

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 24 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.