PERSPECTIVE Study: Real-World CsA 0.1% Efficacy in Keratitis

Theme

The PERSPECTIVE Study

Source
Source: Geerling G, Hamada S, Trocme S, et al. Real-World Effectiveness, Tolerability and Safety of Cyclosporine A 0.1% Cationic Emulsion in Severe Keratitis and Dry Eye Treatment. Ophthalmol Ther. 2022. (The PERSPECTIVE study).

Real-World Evidence Confirming the Long-Term Effectiveness of Cyclosporine A 0.1% in Severe Keratitis

Design

Prospective, multicenter, observational cohort (N=472).
Scope: 44 clinics across 5 European countries.

Population

Adults with severe keratitis & DED insufficiently controlled by artificial tears.

Intervention

CsA 0.1% cationic emulsion (CE) once daily at bedtime (real-world concomitant use permitted).

77.5%
Responders at Month 12

Patients achieving ≥1 grade reduction in Corneal Fluorescein Staining (CFS).

Significant Corneal Healing

Decrease in CFS Score (Oxford Scale) from Baseline to Month 12.

P < 0.0001

Tear Film Stability (TBUT)

Improvement P < 0.001

Symptom Relief

  • Rapid Onset: Significant improvement in pain, burning, and foreign body sensation by Week 4.
  • Sustained Effect: Over 83% of patients reported symptoms improved or stabilized by Month 12.
  • High Tolerability: 80.4% of physicians rated tolerability as "good" or "very good".

Clinical Recommendation

The PERSPECTIVE study bridges the gap between RCTs and daily practice. CsA 0.1% CE is effective and well-tolerated in the heterogeneous patient population seen in clinics. Clinicians should feel confident initiating this therapy early for patients failing artificial tears, with significant improvements in signs and symptoms observable within the first month.

AbbreviationsQuick
AE: adverse event; AT: artificial tear; CE: cationic emulsion; CFS: corneal fluorescein staining; CsA: cyclosporine A; DED: dry eye disease; FAS: full analysis set; QoL: quality of life; SD: standard deviation; TBUT: tear film breakup time; VA: visual acuity.
Bibliography8
  1. Geerling G, Hamada S, Trocme S, et al. Real-World Effectiveness, Tolerability and Safety of Cyclosporine A 0.1% Cationic Emulsion in Severe Keratitis and Dry Eye Treatment. Ophthalmol Ther. 2022. (DOI: 10.1007/s40123-022-00487-x | link)
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  5. Leonardi A, Van Setten G, Amrane M, et al. Efficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease: a multicenter randomized trial. Eur J Ophthalmol. 2016;26(4):287–96.
  6. Baudouin C, de la Maza MS, Amrane M, et al. One-year efficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease. Eur J Ophthalmol. 2017;27(6):678–85.
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  8. US Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff. 2018.
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