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New treatment option for Dry Eye Symptoms
Official title Comparison of Ocular Lubricants in People With Symptoms of Dry Eye
ClinicalTrials.gov ID: NCT07451184
What this study is testing
What is Propylene glycol 0.6%?
Propylene glycol 0.6% is an investigational medicine, given as a twice-daily, being studied as a potential treatment for dry eye symptoms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ocular dryness and discomfort are symptoms commonly associated with dry eye. Lubricating eye drops, also called artificial tears, are often used to moisten the eye and provide relief from these symptoms.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are at least 18 years of age and have full legal capacity to volunteer;
- Have understood and signed an institutional review board (IRB)/ independent ethics committee (IEC) approved informed consent form;
- Are willing and able to attend all study visits as required per protocol;
- Are willing to discontinue use of all habitual artificial tear supplements and use only the study drops as directed for the entire study duration;
- Have dry eye symptomatology as per Tear Film \& Ocular Surface Society Dry Eye WorkShop (TFOS DEWS) II definition:
You likely can't join if
- Have taken part in an treatment clinical study within the previous 14 days before screening;
- Are participating in any concurrent ocular or treatment clinical trial;
- Have any active\ ocular inflammation, infection, or are using ocular topical treatment (other than dry eye drops);
- Started any systemic medication known to cause dry eye (e.g., anti-histamine, antidepressants, benzodiazepines, etc.) within 30 days before...
- Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated;
- Have biomicroscopy signs of grade 3 or more (Efron scale);
See the full eligibility criteria
- Are at least 18 years of age and have full legal capacity to volunteer;
- Have understood and signed an institutional review board (IRB)/ independent ethics committee (IEC) approved informed consent form;
- Are willing and able to attend all study visits as required per protocol;
- Are willing to discontinue use of all habitual artificial tear supplements and use only the study drops as directed for the entire study duration;
- Have dry eye symptomatology as per Tear Film \& Ocular Surface Society Dry Eye WorkShop (TFOS DEWS) II definition:
- Have an Ocular Surface Disease Index (OSDI) score ≥13;
- Have an absence of active\ anterior segment disease;
- Have not worn contact lenses for the previous 14 days before screening, and are willing to not wear contact lenses for the duration of the study;
- Are correctable to a visual acuity of +0.20 LogMAR or better (in at least one eye) with refraction results.
- Have taken part in an treatment clinical study within the previous 14 days before screening;
- Are participating in any concurrent ocular or treatment clinical trial;
- Have any active\ ocular inflammation, infection, or are using ocular topical treatment (other than dry eye drops);
- Started any systemic medication known to cause dry eye (e.g., anti-histamine, antidepressants, benzodiazepines, etc.) within 30 days before screening. Stable dosing for \>30 days before screening is allowed, but changes...
- Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated;
- Have biomicroscopy signs of grade 3 or more (Efron scale);
- Have known sensitivity to the diagnostic pharmaceuticals or to any ingredients in the study products;
- Are pregnant, lactating or planning a pregnancy at the time of enrolment;
- Are a member of the Centre for Ocular Research \& Education directly involved in this study (on the delegation log);
- Are an employee of Alcon.
The study team makes the final eligibility decision.
Where it's taking place
- Waterloo, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Waterloo, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.