PMID- 35298789
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2193-8245 (Print)
IS  - 2193-6528 (Electronic)
VI  - 11
IP  - 3
DP  - 2022 Jun
TI  - Real-World Effectiveness, Tolerability and Safety of Cyclosporine A 0.1% Cationic 
      Emulsion in Severe Keratitis and Dry Eye Treatment.
PG  - 1101-1117
LID - 10.1007/s40123-022-00487-x [doi]
AB  - INTRODUCTION: The PERSPECTIVE study evaluated, in routine clinical practice, the 
      effectiveness, tolerability and safety of cyclosporine A (CsA) 0.1% cationic 
      emulsion (CE) in controlling severe keratitis in adults with dry eye who remained 
      insufficiently controlled despite artificial tear (AT) use. METHODS: A 
      prospective, multicenter, observational study was conducted at 44 ophthalmology 
      clinics across Finland, Germany, Norway, Sweden and the UK. Adults treated with 
      ATs for severe keratitis and dry eye received CsA 0.1% CE therapy (1 drop in both 
      eyes at bedtime) and were followed up at weeks 4, 12 and 24 and at month 12. 
      Primary endpoint was mean [standard deviation (SD)] change from baseline in 
      corneal fluorescein staining (CFS; Oxford Grade Scale) at month 12 following CsA 
      0.1% CE initiation. Secondary endpoints examined ocular sign and symptom severity 
      and adverse events (AEs). RESULTS: The full analysis set included 472 adults 
      (75.9% female). Mean (SD) age was 61.9 (15.41) years. Mean (SD) CFS score was 
      significantly reduced from baseline [2.56 (1.10)] at month 12 [1.10 (SD 1.13); 
      P < 0.0001]. CFS score reductions were statistically significant from week 4, 
      with further incremental decreases reported at study visits through month 12 
      (P < 0.0001). Severity of eyelid and conjunctival erythema was significantly 
      reduced from baseline at week 4 and maintained through month 12 (P < 0.001). Tear 
      film breakup time increased significantly from baseline at all study visits 
      through month 12 (P < 0.001). Ocular symptom severity was significantly reduced 
      from baseline at all study visits through month 12 (P < 0.001). Overall, 101 
      treatment-related AEs were reported. Most were mild/moderate (83.6%) and resolved 
      by month 12 (73.3%). CONCLUSIONS: In routine clinical practice, CsA 0.1% CE 
      provided statistically significant reductions in dry eye signs and symptoms. 
      Improvements were seen at week 4 and maintained over 12 months. Treatment 
      tolerability was good and consistent with previous CsA 0.1% CE clinical studies. 
      TRIAL REGISTRATION: EU PAS register number: EUPAS 22376.
CI  - (c) 2022. The Author(s).
FAU - Geerling, Gerd
AU  - Geerling G
AD  - Department of Ophthalmology, University Hospital Dusseldorf, Dusseldorf, Germany. 
      Geerling@med.uni-duesseldorf.de.
FAU - Hamada, Samer
AU  - Hamada S
AD  - Queen Victoria Hospital, East Grinstead, UK.
FAU - Trocme, Stefan
AU  - Trocme S
AD  - Aleris Specialistvard Sabbatsberg, Europakliniken Department of Ophthalmology, 
      Sabbatsbergs Hospital, Stockholm, Sweden.
FAU - Raeder, Sten
AU  - Raeder S
AD  - The Norwegian Dry Eye Clinic, Oslo, Norway.
FAU - Chen, Xiangjun
AU  - Chen X
AD  - The Norwegian Dry Eye Clinic, Oslo, Norway.
FAU - Fassari, Claudia
AU  - Fassari C
AD  - Santen SA, Geneva, Switzerland.
FAU - Lanzl, Ines
AU  - Lanzl I
AD  - Chiemsee Augentagesklinik, Prien, Germany.
CN  - PERSPECTIVE study group
LA  - eng
PT  - Journal Article
DEP - 20220317
PL  - England
TA  - Ophthalmol Ther
JT  - Ophthalmology and therapy
JID - 101634502
PMC - PMC9114212
OTO - NOTNLM
OT  - Cyclosporine A 0.1% cationic emulsion
OT  - Dry eye disease
OT  - Real-world evidence
OT  - Severe keratitis
EDAT- 2022/03/18 06:00
MHDA- 2022/03/18 06:01
PMCR- 2022/03/17
CRDT- 2022/03/17 17:20
PHST- 2021/12/16 00:00 [received]
PHST- 2022/02/14 00:00 [accepted]
PHST- 2022/03/18 06:00 [pubmed]
PHST- 2022/03/18 06:01 [medline]
PHST- 2022/03/17 17:20 [entrez]
PHST- 2022/03/17 00:00 [pmc-release]
AID - 10.1007/s40123-022-00487-x [pii]
AID - 487 [pii]
AID - 10.1007/s40123-022-00487-x [doi]
PST - ppublish
SO  - Ophthalmol Ther. 2022 Jun;11(3):1101-1117. doi: 10.1007/s40123-022-00487-x. Epub 
      2022 Mar 17.