Contact Lens Related Dry EyeSAFFRONNCT03050125

The Impact of Hypo-osmolar Drops on Contact Lens Comfort

A study testing Hypo-osmolar drop 1, Hypo-osmolar drop 2 and Iso-osmolar drop in people with Contact Lens Related Dry Eye, run by Centre for Contact Lens Research 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

This pilot study will investigate the impact of sterile saline drops that are formulated at hypo-osmolar levels on CL comfort in comparison to an iso-osmolar drop, in a group of symptomatic CL wearers. Read more about this study

Who is it for?: Ages 17 years and olderHealthy volunteers can take part
Conditions the study is for: Contact Lens Related Dry Eye
What is being tested?: Hypo-osmolar drop 1, Hypo-osmolar drop 2 and Iso-osmolar drop
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteCanada
Study dates: 7 Feb 2017to 28 Mar 2017
Phase: Interventional
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

Is at least 17 years of age;
Has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is willing and able to stay within the School of Optometry and Vision Science building for the duration of each Study Day;
Currently wears daily, soft, frequent replacement lenses licensed in Canada (daily, bi-weekly or monthly disposable lenses, no extended wear, no monovision) for at least 3 days/week and 6 hours/day during the 2 months prior to enrolment;

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Is symptomatic according to the following classification:
Reports a difference between average and comfortable wear time with habitual lenses of at least 3 hours;
Fall into the symptomatic group as per Young's criteria (Appendix 4).
Is able to remove and insert the lenses by themselves;
Owns a wearable pair of spectacles;
Is willing to wear the study lenses for 10 hours;
Has visual acuity (VA) correctable to logMAR 0.20 or better in each eye;
Shows an acceptable lens fit with their habitual lenses;

Who cannot join

Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/ or infection;
Has any ocular abnormality that would contraindicate contact lens wear;
Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator may affect the study measures;
Is using any systemic or topical medications that in the option of the investigator may affect the study measures;
Has any known sensitivity to the diagnostic pharmaceuticals and products to be used in this study;

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Is pregnant or lactating (by verbal communication) due to potential ocular physiology changes that may affect the study outcome;
Is aphakic;
Has undergone refractive error surgery;
Is a member of the CCLR directly involved in the data collection. *For the purpose of this study, active ocular disease is defined as an infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered an active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Conditions: Contact Lens Related Dry Eye
Being tested: Hypo-osmolar drop 1, Hypo-osmolar drop 2, Iso-osmolar drop

What participants receive

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

Hypo-osmolar drop 1Device
180 mOsmol sterile saline drops used as a contact lens rewetting drop.
Hypo-osmolar drop 2Device
240 mOsmol sterile saline drops used as a contact lens rewetting drop.
Iso-osmolar dropDevice
300 mOsmol sterile saline drops used as a contact lens rewetting drop.

Study groups in NCT03050125
Study group	Role	What they receive
Hypo-osmolar drop 1	Experimental	Subject will receive regular instillations of hypo-osmolar sterile saline drops with the lowest osmolarity of the two hypo-osmolar drops. Receives: Device: Hypo-osmolar drop 1
Hypo-osmolar drop 2	Experimental	Subject will receive regular instillations of hypo-osmolar sterile saline drops with the highest osmolarity of the two hypo-osmolar drops. Receives: Device: Hypo-osmolar drop 2
Iso-osmolar drop	Experimental	Subject will receive regular instillations of sterile iso-osmolar saline drops. Receives: Device: Iso-osmolar drop

What is being measured

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

Participant's Subjective Rating of Comfort (Questionnaire)
Participants rated their eye comfort by subjective questionnaire (un-annotated scale, 0-100, 0=Very poor comfort, 100=Excellent comfort). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participant's Subjective Rating of Dryness (Questionnaire)
Participants rated the dryness of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Very dry, 100=No dryness at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participant's Subjective Rating of Foreign Body Sensation (Questionnaire)
Participants rated the foreign body sensation of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Intense feeling of foreign body sensation, 100=No foreign body sensation at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participant's Subjective Rating of Stability of Vision (Questionnaire)
Participants rated the stability of their vision by subjective questionnaire (un-annotated scale, 0-100, 0=Not stable at all/ very fluctuating, 100=Very stable). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participant's Subjective Rating of Comfort (Questionnaire) - Likert scale
Participants responded to the statement "My eyes feels comfortable" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participant's Subjective Rating of Dryness (Questionnaire) - Likert scale
Participants responded to the statement "My eyes feel dry" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participant's Subjective Rating of Burning (Questionnaire) - Likert scale
Participants responded to the statement "My eyes burn" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participant's Subjective Rating of Awareness (Questionnaire) - Likert scale
Participants responded to the statement "I am aware of the lenses in my eyes" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participant's Subjective Rating of vision stability (Questionnaire) - Likert scale
Participants responded to the statement "My vision is stable" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Measured: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Drop preference (compared with last drop used)
Participant's subjective response for drop preference (compared with last drop used) at the end of days 2 and 3. (5 possible ratings: Strongly prefer Day 1, Prefer Day 1, No preference, Prefer Day 2, Strongly prefer day 2 OR Strongly Prefer Day 2, Prefer Day 2, No preference, Prefer Day 3, Strongly prefer day 3)
Measured: End of day 2, End of day 3

Secondary outcomes (9)

Tear film osmolarity
Tear film osmolarity in mOsmol/L, measured prior to the first drop of the day and at the end of the day.
Measured: Baseline, End of 1 day
Tear meniscus height
Tear meniscus height in mm, measured prior to the first drop of the day and at the end of the day.
Measured: Baseline, End of 1 day
Non-invasive tear film break-up time (NITBUT)
Measurement of time taken in seconds for a dry spot to appear on the corneal surface after blinking.
Measured: Baseline, End of 1 day
Conjunctival hyperemia
Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
Measured: Baseline, 4.5 hrs, End of 1 Day
Limbal hyperemia
Limbal hyperemia evaluated on a scale from 0 (normal) to 4 (severe).
Measured: Baseline, 4.5 hrs, End of 1 Day
Average corneal staining
Average corneal staining evaluated on a scale from 0 (normal) to 4 (severe).
Measured: Baseline, 4.5 hrs, End of 1 Day
Lens movement
Amount of lens movement on blink (mm).
Measured: Baseline, 4.5 hrs, End of 1 Day
Lens lag
Amount of lens lag on blink (mm).
Measured: Baseline, 4.5 hrs, End of 1 Day
Lens Tightness
Amount of lens tightness (%).
Measured: Baseline, 4.5 hrs, End of 1 Day

Timeline

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

7 Feb 201728 Mar 2017

First posted10 Feb 2017
Study start7 Feb 2017
Primary completion28 Mar 2017
Study completion28 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Contact Lens Related Dry EyeStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03050125
Sponsor's protocol ID: 21907
Acronym: SAFFRON
Status last verified: May 2017
First submitted: 8 Feb 2017
Last updated: 4 May 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Hypo-osmolar Drops on Contact Lens Comfort
ClinicalTrials.gov ID: NCT03050125
Acronym / sponsor ID: SAFFRON / 21907
Conditions: Contact Lens Related Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Centre for Contact Lens ResearchUniversity, hospital or other
Collaborators: CooperVision, Inc.
Study start: 7 Feb 2017 (actual)
Primary completion: 28 Mar 2017 (actual)
Study completion: 28 Mar 2017 (actual)
First posted: 10 Feb 2017 (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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Hypo-osmolar drop 1	Experimental	Device: Hypo-osmolar drop 1Subject will receive regular instillations of hypo-osmolar sterile saline drops with the lowest osmolarity of the two hypo-osmolar drops.
Hypo-osmolar drop 2	Experimental	Device: Hypo-osmolar drop 2Subject will receive regular instillations of hypo-osmolar sterile saline drops with the highest osmolarity of the two hypo-osmolar drops.
Iso-osmolar drop	Experimental	Device: Iso-osmolar dropSubject will receive regular instillations of sterile iso-osmolar saline drops.

Who may qualify

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

Key inclusion criteria (14 listed)

Is at least 17 years of age;
Has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is willing and able to stay within the School of Optometry and Vision Science building for the duration of each Study Day;

Key exclusion criteria (10 listed)

Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/ or infection;
Has any ocular abnormality that would contraindicate contact lens wear;
Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator may affect the study measures;
Is using any systemic or topical medications that in the option of the investigator may affect the study measures;

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
Hypo-osmolar drop 1180 mOsmol sterile saline drops used as a contact lens rewetting drop.	Device	Hypo-osmolar drop 1
Hypo-osmolar drop 2240 mOsmol sterile saline drops used as a contact lens rewetting drop.	Device	Hypo-osmolar drop 2
Iso-osmolar drop300 mOsmol sterile saline drops used as a contact lens rewetting drop.	Device	Iso-osmolar drop

Primary outcome

Participant's Subjective Rating of Comfort (Questionnaire)
Time frame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participants rated their eye comfort by subjective questionnaire (un-annotated scale, 0-100, 0=Very poor comfort, 100=Excellent comfort). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Dryness (Questionnaire)
Time frame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participants rated the dryness of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Very dry, 100=No dryness at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Foreign Body Sensation (Questionnaire)
Time frame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participants rated the foreign body sensation of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Intense feeling of foreign body sensation, 100=No foreign body sensation at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Stability of Vision (Questionnaire)
Time frame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participants rated the stability of their vision by subjective questionnaire (un-annotated scale, 0-100, 0=Not stable at all/ very fluctuating, 100=Very stable). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Comfort (Questionnaire) - Likert scale
Time frame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "My eyes feels comfortable" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Dryness (Questionnaire) - Likert scale
Time frame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "My eyes feel dry" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Burning (Questionnaire) - Likert scale
Time frame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "My eyes burn" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Awareness (Questionnaire) - Likert scale
Time frame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "I am aware of the lenses in my eyes" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of vision stability (Questionnaire) - Likert scale
Time frame: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "My vision is stable" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Drop preference (compared with last drop used)
Time frame: End of day 2, End of day 3
Participant's subjective response for drop preference (compared with last drop used) at the end of days 2 and 3. (5 possible ratings: Strongly prefer Day 1, Prefer Day 1, No preference, Prefer Day 2, Strongly prefer day 2 OR Strongly Prefer Day 2, Prefer Day 2, No preference, Prefer Day 3, Strongly prefer day 3)

9 secondary outcomes

Tear film osmolarity
Time frame: Baseline, End of 1 day
Tear meniscus height
Time frame: Baseline, End of 1 day
Non-invasive tear film break-up time (NITBUT)
Time frame: Baseline, End of 1 day
Conjunctival hyperemia
Time frame: Baseline, 4.5 hrs, End of 1 Day
Limbal hyperemia
Time frame: Baseline, 4.5 hrs, End of 1 Day
Average corneal staining
Time frame: Baseline, 4.5 hrs, End of 1 Day
Lens movement
Time frame: Baseline, 4.5 hrs, End of 1 Day
Lens lag
Time frame: Baseline, 4.5 hrs, End of 1 Day
Lens Tightness
Time frame: Baseline, 4.5 hrs, End of 1 Day

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 4 May 2017.
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Hypo-osmolar drop 1, Hypo-osmolar drop 2 and Iso-osmolar drop in people with Contact Lens Related Dry Eye, run by Centre for Contact Lens Research 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 14 inclusion and 10 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 4 May 2017. 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.

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?

Participant's Subjective Rating of Comfort (Questionnaire) (time frame: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day). The study lists 10 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 NCT03050125.

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 4 May 2017.