PERSPECTIVE Study: Cyclosporine A 0.1% CE Real-World Evidence

Theme

Real-World Evidence: Cyclosporine A 0.1% CE

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

Delivering sustained corneal surface recovery and symptom relief over 12 months (PERSPECTIVE Study)

Study Architecture & Methodology

Study Design Prospective, multicenter, observational real-world evidence (RWE) study assessing routine clinical practice.
Patient Population 472 adults diagnosed with severe keratitis and DED who were inadequately controlled by artificial tears.
Follow-up Schedule 12-month observation period with data collected at Baseline, Week 4, Week 12, Week 24, and Month 12.
Primary Objectives Evaluate the long-term effectiveness (CFS reduction), safety profile, and tolerability of Cyclosporine A 0.1% CE.
Corneal Fluorescein Staining (CFS) Reduction
Patients demonstrating reduction by Month 12
77.5%
>2 grades reduced (47.5%)

Clinical Sign Reduction

P < 0.0001 vs Baseline

Inflammation Control

P < 0.001 (Conjunctival Erythema)

Tear Film Stability

P < 0.001 (TBUT Increase)

Clinical Recommendation

Integrate CsA 0.1% CE early for patients symptomatic on artificial tears. The PERSPECTIVE study validates efficacy in a real-world setting, confirming that earlier intervention prevents disease progression.
Rapid Onset: Significant improvements by Week 4.
High Tolerability: 83.6% of AEs were mild/moderate.
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)
  2. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276–83.
  3. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575–628.
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  5. Leonardi A, Messmer EM, Labetoulle M, et al. Efficacy and safety of 0.1% ciclosporin A cationic emulsion in dry eye disease: a pooled analysis of two double-masked, randomised, vehicle-controlled phase III clinical studies. Br J Ophthalmol. 2019;103(1):125–31.
  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.
  7. Baudouin C, Figueiredo FC, Messmer EM, et al. A randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eye. Eur J Ophthalmol. 2017;27(5):520–30.
  8. European Medicines Agency. Ikervis Summary of product characteristics. Last review March 2020. (link)
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