Dry EyeCORGINCT04105842
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
A study testing Delfilcon A in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this study is to refit habitual wearers of daily disposable contact lenses who currently experience symptoms of dry eye and discomfort during lens wear with a different type of daily disposable contact lens. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Delfilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2019to 28 Jul 2022
- 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 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 and 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;
- As per TFOS DEWS II, have dry eye symptoms (without CL wear) as determined by an OSDI score of ≥13 and at least one of the following:
- Tear osmolarity ≥ 308mOsm/L or interocular difference >8 mOsm/L
- Non-invasive tear breakup time of < 10 seconds in at least one eye
Show all 13Show fewer
- More than 5 spots of corneal staining OR > 9 conjunctival spots in at least one eye
- Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203
- Habitually wears soft spherical DD CLs with a power between +6.00D and -10.00D
- Manifest spectacle cyl ≤1.00DC in either eye
- BCVA ≤0.20 log MAR each eye with habitual \& DT1
- Acceptable fit with habitual \& DT1
- Willing to wear DT1 CLs at least 3 days per week and 6 hours per day throughout the study
Who cannot join
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
Show all 12Show fewer
- Is aphakic;
- Has undergone refractive error surgery;
- Has taken part in another clinical research study within the last 14 days;
- Current habitual wearer of DT1
- Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.
- For the purposes of this study, active ocular disease is defined as infection or inflammation which 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 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.
About this study
The purpose of this study is to refit habitual wearers of daily disposable contact lenses who currently experience symptoms of dry eye and discomfort during lens wear with a different type of daily disposable contact lens. Ocular signs and symptoms of dry eye will be assessed following the guidelines outlined by the Tear Film and Ocular Surface Society (TFOS) in the Dry Eye Workshop II (DEWS II). The performance of the habitual contact lenses and the study lenses will be determined using different optometric assessments. Study lenses will be worn for one month following a daily disposable wear schedule.
- Conditions
- Dry Eye
- Being tested
- Delfilcon A
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delfilcon ADevice
Also called Dailies Total 1
Participants wear delafilcon A contact lenses on a daily disposable basis.
| Study group | Role | What they receive |
|---|---|---|
| Delfilcon A | Experimental | All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Receives: Device: Delfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 1 after screening with habitual lenses
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 3 after screening with habitual lenses
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 5 after screening with habitual lenses
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: 1-week follow up with habitual lens
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 1 after dispense with delefilcon A
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 3 after dispense with delefilcon A
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 5 after dispense with delefilcon A
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 7 after dispense with delefilcon A
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 21 after dispense with delefilcon A
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: Day 28 after dispense with delefilcon A
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Measured: 1-month follow up with delefilcon A
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 1 after screening with habitual lenses
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 3 after screening with habitual lenses
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 5 after screening with habitual lenses
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: 1-week follow up with habitual lens
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 1 after dispense with delefilcon A
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 3 after dispense with delefilcon A
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 5 after dispense with delefilcon A
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 7 after dispense with delefilcon A
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 21 after dispense with delefilcon A
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: Day 28 after dispense with delefilcon A
Subjective Rating of End of Day Dryness With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Measured: 1-month follow up with delefilcon A
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 1 after screening with habitual lenses
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 3 after screening with habitual lenses
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 5 after screening with habitual lenses
Average Lens Wear Time
Average lens wear time is recorded
Measured: 1-week follow up with habitual lens
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 1 after dispense with delefilcon A
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 3 after dispense with delefilcon A
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 5 after dispense with delefilcon A
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 7 after dispense with delefilcon A
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 21 after dispense with delefilcon A
Average Lens Wear Time
Average lens wear time is recorded
Measured: Day 28 after dispense with delefilcon A
Average Lens Wear Time
Average lens wear time is recorded
Measured: 1-month follow up with delefilcon A
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 1 after screening with habitual lenses
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 3 after screening with habitual lenses
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 5 after screening with habitual lenses
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: 1-week follow up with habitual lens
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 1 after dispense with delefilcon A
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 3 after dispense with delefilcon A
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 5 after dispense with delefilcon A
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 7 after dispense with delefilcon A
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 21 after dispense with delefilcon A
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: Day 28 after dispense with delefilcon A
Comfortable Lens Wear Time
Comfortable lens wear time (Time of discomfort - Time of insertion)
Measured: 1-month follow up with delefilcon A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start23 Sep 2019
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
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 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, FCOptom, Principal investigator, Centre for Ocular Research & Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105842
- Sponsor's protocol ID
- 41251
- Acronym
- CORGI
- Status last verified
- Jun 2023
- First submitted
- 13 Sep 2019
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
- ClinicalTrials.gov ID
- NCT04105842
- Acronym / sponsor ID
- CORGI / 41251
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Posted 29 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to refit habitual wearers of daily disposable contact lenses who currently experience symptoms of dry eye and discomfort during lens wear with a different type of daily disposable contact lens. Ocular signs and symptoms of dry eye will be assessed following the guidelines outlined by the Tear Film and Ocular Surface Society (TFOS) in the Dry Eye Workshop II (DEWS II). The performance of the habitual contact lenses and the study lenses will be determined using different optometric assessments. Study lenses will be worn for one month following a daily disposable wear schedule.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delfilcon A | Experimental | Device: Delfilcon AAll study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Is at least 17 years of age and 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;
- As per TFOS DEWS II, have dry eye symptoms (without CL wear) as determined by an OSDI score of ≥13 and at least one of the following:
- Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203
Key exclusion criteria (12 listed)
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
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 |
|---|---|---|
| Delfilcon AAlso: Dailies Total 1Participants wear delafilcon A contact lenses on a daily disposable basis. | Device | Delfilcon A |
Primary outcome
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 1 after screening with habitual lenses
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 3 after screening with habitual lenses
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 5 after screening with habitual lenses
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: 1-week follow up with habitual lens
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 1 after dispense with delefilcon A
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 3 after dispense with delefilcon A
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 5 after dispense with delefilcon A
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 7 after dispense with delefilcon A
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 21 after dispense with delefilcon A
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: Day 28 after dispense with delefilcon A
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
Time frame: 1-month follow up with delefilcon A
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 1 after screening with habitual lenses
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 3 after screening with habitual lenses
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 5 after screening with habitual lenses
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: 1-week follow up with habitual lens
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 1 after dispense with delefilcon A
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 3 after dispense with delefilcon A
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 5 after dispense with delefilcon A
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 7 after dispense with delefilcon A
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 21 after dispense with delefilcon A
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: Day 28 after dispense with delefilcon A
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear
Time frame: 1-month follow up with delefilcon A
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Average Lens Wear Time
Time frame: Day 1 after screening with habitual lenses
Average lens wear time is recorded
Average Lens Wear Time
Time frame: Day 3 after screening with habitual lenses
Average lens wear time is recorded
Average Lens Wear Time
Time frame: Day 5 after screening with habitual lenses
Average lens wear time is recorded
Average Lens Wear Time
Time frame: 1-week follow up with habitual lens
Average lens wear time is recorded
Average Lens Wear Time
Time frame: Day 1 after dispense with delefilcon A
Average lens wear time is recorded
Average Lens Wear Time
Time frame: Day 3 after dispense with delefilcon A
Average lens wear time is recorded
Average Lens Wear Time
Time frame: Day 5 after dispense with delefilcon A
Average lens wear time is recorded
Average Lens Wear Time
Time frame: Day 7 after dispense with delefilcon A
Average lens wear time is recorded
Average Lens Wear Time
Time frame: Day 21 after dispense with delefilcon A
Average lens wear time is recorded
Average Lens Wear Time
Time frame: Day 28 after dispense with delefilcon A
Average lens wear time is recorded
Average Lens Wear Time
Time frame: 1-month follow up with delefilcon A
Average lens wear time is recorded
Comfortable Lens Wear Time
Time frame: Day 1 after screening with habitual lenses
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: Day 3 after screening with habitual lenses
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: Day 5 after screening with habitual lenses
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: 1-week follow up with habitual lens
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: Day 1 after dispense with delefilcon A
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: Day 3 after dispense with delefilcon A
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: Day 5 after dispense with delefilcon A
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: Day 7 after dispense with delefilcon A
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: Day 21 after dispense with delefilcon A
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: Day 28 after dispense with delefilcon A
Comfortable lens wear time (Time of discomfort - Time of insertion)
Comfortable Lens Wear Time
Time frame: 1-month follow up with delefilcon A
Comfortable lens wear time (Time of discomfort - Time of insertion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- 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.
Lyndon Jones, PhD, 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 study testing Delfilcon A in people with Dry Eye, 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 13 inclusion and 12 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 25 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2023). 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?
Subjective Comfort at End of Day With Contact Lens Wear (time frame: Day 1 after screening with habitual lenses). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2023.