PMID- 36574848
OWN - NLM
STAT- MEDLINE
DCOM- 20230425
LR  - 20230425
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 130
IP  - 5
DP  - 2023 May
TI  - NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of 
      the Randomized Phase 3 GOBI Study.
PG  - 516-524
LID - S0161-6420(22)01016-8 [pii]
LID - 10.1016/j.ophtha.2022.12.021 [doi]
AB  - PURPOSE: To evaluate the efficacy and safety of NOV03 (perfluorohexyloctane) 
      ophthalmic drop in patients with dry eye disease (DED) associated with meibomian 
      gland dysfunction (MGD). DESIGN: Eight-week, phase 3, multicenter, randomized, 
      double-masked, saline-controlled study. PARTICIPANTS: Adults >/= 18 years with a 
      history of DED for >/= 6 months, tear film breakup time of </= 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). METHODS: Patients were randomized 1:1 to NOV03 or 
      hypotonic (0.6%) saline 4 times daily. MAIN OUTCOME MEASURES: The primary sign 
      and symptom end points were change from baseline in tCFS and eye dryness score 
      (0-100 visual analog scale [VAS]) at week 8. Key secondary end points were change 
      from baseline in eye dryness score at week 2, tCFS at week 2, eye burning or 
      stinging score (0-100 VAS) at week 8, and central corneal fluorescein staining 
      (cCFS; 0-3 NEI scale) at week 8. RESULTS: Of the 599 patients randomized, 597 
      were treated (NOV03, n = 303; saline, n = 294). At week 8, improvement from 
      baseline was significantly greater (P < 0.001) with NOV03 versus saline for tCFS 
      (least square [LS] mean treatment difference, -0.97; 95% confidence interval 
      [CI]: -1.40, -0.55) and VAS dryness score (-7.6; 95% CI: -11.8, -3.4). 
      Improvement from baseline also significantly (P < 0.01) favored NOV03 on all key 
      secondary end points: 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 or stinging score at week 8, and -0.2 (-0.4, -0.1) 
      for cCFS at week 8. Most ocular adverse events (AEs) were mild in severity; no 
      serious ocular AEs occurred. One patient discontinued NOV03 because of an AE (eye 
      irritation). CONCLUSIONS: In patients with DED associated with MGD, NOV03 
      demonstrated statistically significant and clinically meaningful improvements 
      versus hypotonic saline in signs and symptoms of DED and was well tolerated. 
      FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after 
      the references.
CI  - Copyright (c) 2023 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Tauber, Joseph
AU  - Tauber J
AD  - Tauber Eye Center, Kansas City, Missouri.
FAU - Berdy, Gregg J
AU  - Berdy GJ
AD  - Ophthalmology Associates, St. Louis, Missouri.
FAU - Wirta, David L
AU  - Wirta DL
AD  - Eye Research Foundation, Newport Beach, California.
FAU - Krosser, Sonja
AU  - Krosser S
AD  - Novaliq GmbH, Heidelberg, Germany.
FAU - Vittitow, Jason L
AU  - Vittitow JL
AD  - Bausch + Lomb, Bridgewater, New Jersey. Electronic address: 
      Jason.Vittitow@bausch.com.
CN  - GOBI Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20221224
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
RN  - TPY09G7XIR (Fluorescein)
RN  - 0 (Ophthalmic Solutions)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Meibomian Gland Dysfunction
MH  - Fluorescein
MH  - *Dry Eye Syndromes/diagnosis/drug therapy/etiology
MH  - Double-Blind Method
MH  - Ophthalmic Solutions
MH  - Tears
MH  - Meibomian Glands
OTO - NOTNLM
OT  - Clinical trial
OT  - Dry eye disease
OT  - Meibomian gland dysfunction
OT  - NOV03
OT  - Perfluorohexyloctane
FIR - Alpern, Louis M
IR  - Alpern LM
FIR - Aune, Carol
IR  - Aune C
FIR - Berdy, Gregg J
IR  - Berdy GJ
FIR - Downing, Johnathon Eric
IR  - Downing JE
FIR - El-Harazi, Sherif
IR  - El-Harazi S
FIR - Evans, David G
IR  - Evans DG
FIR - Goldberg, Damien
IR  - Goldberg D
FIR - Greiner, Jack
IR  - Greiner J
FIR - Holland, Edward
IR  - Holland E
FIR - Jackson, Mitchell A
IR  - Jackson MA
FIR - Jerkins, Gary W
IR  - Jerkins GW
FIR - Kelley, Kathleen
IR  - Kelley K
FIR - Martel, Joseph
IR  - Martel J
FIR - Meyer, Joseph L
IR  - Meyer JL
FIR - Pasquali, Theodore
IR  - Pasquali T
FIR - Paul, Matthew D
IR  - Paul MD
FIR - Perez, Bernard R
IR  - Perez BR
FIR - Rashid, Edward R
IR  - Rashid ER
FIR - Rhodes, Kyle
IR  - Rhodes K
FIR - Robben, Jerry
IR  - Robben J
FIR - Lee Shettle, Philip
IR  - Lee Shettle P
FIR - Smith, Stephen E
IR  - Smith SE
FIR - Smyth-Medina, Robert John
IR  - Smyth-Medina RJ
FIR - Tauber, Joseph
IR  - Tauber J
FIR - Wirta, David
IR  - Wirta D
FIR - Zimmer, Daniel V
IR  - Zimmer DV
EDAT- 2022/12/28 06:00
MHDA- 2023/04/25 10:19
CRDT- 2022/12/27 19:11
PHST- 2022/06/30 00:00 [received]
PHST- 2022/11/29 00:00 [revised]
PHST- 2022/12/20 00:00 [accepted]
PHST- 2023/04/25 10:19 [medline]
PHST- 2022/12/28 06:00 [pubmed]
PHST- 2022/12/27 19:11 [entrez]
AID - S0161-6420(22)01016-8 [pii]
AID - 10.1016/j.ophtha.2022.12.021 [doi]
PST - ppublish
SO  - Ophthalmology. 2023 May;130(5):516-524. doi: 10.1016/j.ophtha.2022.12.021. Epub 
      2022 Dec 24.