Table 3.
Clinical Studies of PG-HPG Nanoemulsion Lubricant Eye Drops in Improvement of Contact Lens Discomfort
| Study Treatment | Outcome Parameters | Results |
|---|---|---|
| Pucker et al, 2020;53 A prospective, investigator-masked, two-week, randomized clinical trial in symptomatic contact lens wearers (N=46) | ||
| PG-HPG nanoemulsion (SystaneTM Complete) vs no treatment | Contact lens comfort and dry eye: CLDEQ-4, CLDEQ-8, and SPEED scores | CLDEQ-8 score (mean±SD): Baseline: 20.41±5.40 vs 18.92±4.92, p=0.25 2-week: 12.86±6.40 vs 17.92±5.30, p=0.006 Difference from baseline at week 2: 7.55±4.96, p<0.0001 vs 1.00±4.11, p=0.26 CLDEQ-4 score (mean±SD): Baseline: 10.91±3.28 vs 10.38±2.41, p=0.42 2-week: 7.14±3.50 vs 10.13±2.83, p=0.005 Difference from baseline at week 2: 3.77±2.65, p<0.0001 vs 0.25±2.42, p=0.56 SPEED score (mean±SD): Baseline: 10.27±3.60 vs 9.67±3.93, p=0.90 2-week: 7.55±4.31 vs 9.29±4.14, p=0.17 Difference from baseline at week 2: 2.72±2.86, p<0.0001 vs 0.38±3.66, p=1.00 |
| Self-perceived eye comfort | Self-perceived eye comfort at 2 weeks: Same: 31.82% vs 83.33%; better: 59.09% vs 0.0%; worse: 9.09% vs 16.7%; p<0.0001 |
|
| Safety: AEs | No AEs were reported during the study | |
| Pucker et al, 2021;54 A two-week, two-visit, prospective, double-masked, multicenter, randomized, clinical study in participants with contact lens discomfort (N=73) | ||
| PG-HPG nanoemulsion (SystaneTM Complete) vs rewetting drops (Sensitive Eyes) vs no treatment | Contact lens comfort and dry eye symptoms: CLDEQ-8 and SPEED scores | CLDEQ-8 score (mean±SD): Baseline: 20.6±5.3 vs 20.5±5.5 vs 21.8±5.0, p=0.67 2-week: 14.7±5.3 vs 14.8±4.7 vs 21.2±6.0, group comparison p<0.0001 (artificial tears vs rewetting drops, p=0.94) Difference from baseline: 6.0±6.3, p<0.0001 vs 5.8±4.3, p<0.0001 vs 0.5±3.8, p=0.49 SPEED score (mean±SD): Baseline: 9.4±3.9 vs 10.3±4.6 vs 10.7±5.0, p=0.61 2-week: 7.3±3.1 vs 8.4±4.6 vs 10.2±4.9, group comparison p=0.065 (artificial tears vs rewetting drops, p=0.37) Difference from baseline: 2.1±4.1, p=0.016 vs 1.8±4.3, p=0.0495 vs 0.5±3.6, p=0.50 |
| Self-perceived eye comfort | Self-perceived eye comfort at 2-weeks: Same: 44% vs 21% vs 75%; better: 52% vs 79% vs 4%; worse: 4% vs 0% vs 21%; group comparison p<0.0001 (artificial tears vs rewetting drops, p=0.15) |
|
| End-of-day contact lens comfort just prior to removal (VAS 0–100 scale) | VAS scores (mean±SD): 1-week: 58.56±21.44 vs 63.00±27.14 vs 44.25±28.95, group comparison p=0.038 (artificial tears vs rewetting drops, p=0.55) 2-week: 62.96±26.80 vs 71.38±21.85 vs 40.29±31.07, group comparison p=0.0004 (artificial tears vs rewetting drops, p=0.28) |
|
| Safety: AEs | No AEs were self-reported or detected during the study | |
| Tan et al, 2022;55 A prospective, single-center, nondispending, randomized, double-masked, 3-arm comparative study in participants using miniscleral contact lenses (N=24) | ||
| PG-HPG nanoemulsion (SystaneTM Complete) and HPG/HA eye drop (SystaneTM Hydration) vs saline | Dry eye symptoms | Percentage of patients reporting dryness symptom improvement at 5 min after lens application: Dryness: 50% and 42% vs 0% Improvement in symptoms (estimate±standard error), p-value vs saline (negative statistics: less symptoms at a time point earlier than saline): Dryness: −1.69±0.58, p=0.005 and −1.13±0.56, p=0.049 fluctuation of vision: −1.50±0.57, p=0.011 and −0.15±0.56, p=0.78 Grittiness, burning, and stinging: −1.99±0.58, p=0.001 and −0.84±0.56, p=0.14 Foreign body sensation: −1.61±0.57, p=0.006 and −0.44±0.55, p=0.43 |
Abbreviations: AEs, adverse events; CLDEQ-4, contact lens dry eye questionnaire-4; CLDEQ-8, contact lens dry eye questionnaire-8; HA, hyaluronic acid; HPG, hydroxypropyl guar; PG, propylene glycol; SD, standard deviation; SPEED, standard patient evaluation of eye dryness questionnaire; VAS, visual analog scale.