| Popis: |
To evaluate the efficacy and safety of NOV03 (perfluorohexyloctane) ophthalmic drop in patients with dry eye disease (DED) associated with meibomian gland dysfunction (MGD).Eight-week, phase 3, multicenter, randomized, double-masked, saline-controlled study.Adults aged ≥18 years with a history of DED for ≥6 months, tear film breakup time ≤5 seconds, Schirmer I test (without anesthesia) score ≥5 mm, MGD score ≥3 (0-15 scale), and total corneal fluorescein staining (tCFS) score ≥4 and ≤11 (0-15 National Eye Institute [NEI] scale).Patients were randomized 1:1 to receive NOV03 or hypotonic (0.6%) saline 4 times daily.The primary sign endpoint was change from baseline at Week 8 in tCFS. The primary symptom endpoint was change from baseline at Week 8 in eye dryness score (0-100 visual analog scale [VAS]). Key secondary endpoints were change from baseline in eye dryness score at Week 2, tCFS at Week 2, eye burning/stinging score (0-100 VAS) at Week 8, and central corneal fluorescein staining (cCFS; 0-3 NEI scale) at Week 8.A total of 597 patients were randomized and treated (NOV03, 303; saline, 294). At Week 8, improvement from baseline was significantly greater with NOV03 versus saline for both tCFS (least-squares [LS] mean treatment difference, -0.97; 95% confidence interval [CI]: -1.40, -0.55; P0.001) and VAS dryness score (LS mean treatment difference, -7.6; 95% CI: -11.8, -3.4; P0.001). Improvement from baseline also significantly favored NOV03 on all key secondary endpoints: LS mean treatment difference (95% CI) was -4.7 (-8.2, -1.2) for VAS dryness score at Week 2, -0.6 (-0.9, -0.2) for tCFS at Week 2, -5.5 (-9.5, -1.6) for VAS burning/stinging score at Week 8, and -0.2 (-0.4, -0.1) for cCFS at Week 8; all P0.01. Most ocular adverse events were mild in severity; there were no serious ocular adverse events. One patient discontinued NOV03 due to an adverse event (eye irritation).In patients with DED associated with MGD, NOV03 eye drops demonstrated statistically significant and clinically meaningful improvements versus hypotonic saline in both the signs and symptoms of DED. NOV03 appeared well tolerated in this population. |
