An interventional study of Propylene glycol-based eye drops in Dry Eye Disease, sponsored by Alcon Research. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-12.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
Among 85 studies in Dry Eye Syndromes by Alcon Research — 1 open to participants now, 1 under way, none of them phase 3. Dry Eye Syndromes · Alcon Research.
Among the 85 studies in Dry Eye Syndromes by Alcon Research, this one is the 18th largest by enrollment of the 81 interventional ones that give a count, is the only one that started in 2018, is one of 62 with no phase, and was the 66th registered.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
Browse Dry Eye Syndromes studies →1 of the 85 studies in Dry Eye Syndromes by Alcon Research is open now, in 1 country. Recruiting first, the newest first:
Alcon Research · Sites in United States
By country, each count listing its studies:
Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
85 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 134 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Median enrollment 60 across the 81 interventional studies, 79 across the 4 observational. Of the 83 that completed or were terminated, 32 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
1 of the studies in Dry Eye Syndromes by Alcon Research that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07768735Alcon ResearchUNITY DX Cornea Study | 2026-11 |
Among the 85 studies in Dry Eye Syndromes by Alcon Research, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.
Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-specified inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Propylene glycol-based eye drops, 1 drop in each eye twice a day (BID) (morning and evening) for 28 days. Patients can administer additional doses in between the scheduled daily doses as needed
Other: Propylene glycol-based eye drops
Nano-emulsion ocular lubricant
Also known as: SYSTANE® Complete
Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
TFBUT will be assessed using fluorescein, an ocular staining dye
Time frame: Baseline, Day 14
Change from baseline in dry eye symptom score at Day 1
As reported by the patient using a Likert scale post drop instillation
Time frame: Baseline, Day 1
Soothing sensation score
As reported by the patient using a Likert scale post drop instillation
Time frame: Day 1
Tolerability assessment score
As reported by the patient using an assessment questionnaire post drop instillation
Time frame: Day 1
Change from baseline in ocular discomfort at Day 14
As reported by the patient using a Visual Analogue Scale (VAS)
Time frame: Baseline, Day 14
Change from baseline in corneal staining score at Day 28
Assessment of ocular staining using staining dye under a slit lamp
Time frame: Baseline, Day 28
Change from baseline in response to the revised IDEEL questionnaire at Day 28
As reported by the patient using a subjective questionnaire
Time frame: Baseline, Day 28
Change from baseline in EQ-5D-5L score(s) at Day 28
As reported by the patient using a validated questionnaire
Time frame: Baseline, Day 28
Change from baseline in TFBUT at Day 28
TFBUT will be assessed using fluorescein, an ocular staining dye
Time frame: Baseline, Day 28
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Apr 2019, 9 months.
Of 113 industry-sponsored interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 9 months is close to that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.