Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial
Bibliographic record
Abstract
Steven Silverstein,1 Elizabeth Yeu,2 Joseph Tauber,3 Michel Guillon,4 Lyndon Jones,5,6 David Galarreta,7 Sruthi Srinivasan,8 Venkiteshwar Manoj8 1Silverstein Eye Centers, Kansas City, MO 64133, USA; 2Virginia Eye Consultants, Norfolk, VA 23502, USA; 3Tauber Eye Center, Kansas City, MO 64155, USA; 4Ocular Technology Group International, London SW1E 6AU, UK; 5Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, Waterloo, ON NL2 3G1, Canada; 6Centre for Eye and Vision Research Limited (CEVR), Hong Kong; 7Hospital Clinico Universitario de Valladolid, Valladolid Castilla y Leon 47011, Spain; 8Alcon Research, LLC, Johns Creek, GA, USACorrespondence: Steven SilversteinSilverstein Eye Centers, Kansas City, MO 64133, USATel +1 816.358.3600Fax +1 816.358.1887Email ssilverstein@silversteineyecenters.comPurpose: To evaluate symptom relief in patients with dry eye disease (DED) following a single drop of propylene glycol-hydroxypropyl guar (PG-HPG) nanoemulsion (Systane® Complete) lubricant eye drops.Methods: This was a Phase IV, multicenter, open-label, interventional study in adult patients with DED of aqueous-deficient, evaporative, and mixed subtypes. Patients instilled one drop of PG-HPG in each eye at Day 1. Endpoints included change from baseline in dry eye symptom and soothing sensation scores on Day 1 at 0, 4, and 8 hours post-dose. Symptom scores were assessed on a 0– 10 scale (0=no symptoms; 10=worst imaginable symptom). Tolerability of the drop was assessed based on assessment score on Day 1 following instillation for overall cohort and by DED subtype.Results: A total of 134 patients received treatment (mean age: 56.6 years; female: 75.4%). Median changes from baseline at Day 1 in dry eye symptom scores were − 1.0 (95% confidence interval [CI]:-3.0,-1.0), − 2.0 (95% CI:-3.0,-2.0), and − 2.0 (95% CI:-2.0,-1.0) at 0, 4, and 8 hours respectively. Subgroup analysis showed a median change from baseline in dry eye symptom score of − 2 (95% CI:-3.0,-1.0) for aqueous-deficient and evaporative subtypes and − 1 (95% CI:-3.0,-1.0) for mixed subtype at 8 hours. Median soothing sensation scores were 3 at 0 and 4 hours and 3.5 at 8 hours, with a range of 0– 10. Median (range) tolerability assessment scores were 0 (0– 8) for burning sensation, stinging sensation, blurring, and 0 (0– 10) for foreign body sensation. Tolerability assessment scores by DED subtype confirmed that the majority of patients reported scores in the range of 0– 5 for all components and in all subgroups analyzed.Conclusion: Our study demonstrated that PG-HPG nanoemulsion provided instant/immediate and sustained symptom relief for 8 hours post-single application and was well tolerated in patients with DED, demonstrated by their responses on each of the assessment scales.Keywords: aqueous-deficient dry eye, dry eye disease, evaporative dry eye, propylene glycol-hydroxypropyl guar nanoemulsion ocular lubricant, mixed dry eye
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".