Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose

Stephen Cohen, Anna Martin, Kenneth Sall, Stephen Cohen, Anna Martin, Kenneth Sall

Abstract

Background: The purpose of this study was to compare changes in corneal staining in patients with dry eye after 6 weeks of treatment with Systane® Gel Drops or Refresh Liquigel® lubricant eye drops.

Methods: Patients aged ≥18 years with a sodium fluorescein corneal staining sum score of ≥3 in either eye and best-corrected visual acuity of 0.6 logarithm of the minimum angle of resolution or better in each eye who were using a lubricant eye gel or ointment for dry eye were included in this randomized, parallel-group, multicenter, double-blind trial. Patients were randomized to four times daily Systane® Gel Drops (polyethylene glycol 400 0.4% and propylene glycol 0.3%) or Refresh LiquiGel® Drops (carboxymethylcellulose sodium 1%) for 6 weeks. The primary efficacy outcome was mean change from baseline to week 6 in sodium fluorescein corneal staining. Supportive efficacy outcomes included conjunctival staining, tear film break-up time, Patient Global Assessment of Improvement, Impact of Dry Eye on Everyday Life (IDEEL) Treatment Satisfaction/Treatment Bother Questionnaire, Single Symptom Comfort Scale, and Ocular Symptoms Questionnaire. The safety analysis comprised recording of adverse events.

Results: In total, 147 patients (Systane group, n=73; Refresh group, n=74; mean ± standard deviation age, 57±16 years) were enrolled and included in the safety and efficacy analyses. Corneal staining was significantly reduced from baseline to week 6 for Systane and Refresh (-3.4±2.5 and -2.5±2.6 units, respectively; P<0.0001, t-test), with a significantly greater improvement with Systane versus Refresh (P=0.0294). Results for conjunctival staining, tear film break-up time, and patient-reported outcome questionnaires were not statistically different between groups. No safety issues were identified; adverse events were reported by 19% of patients with Systane and 30% of patients with Refresh eye drops.

Conclusion: Systane Gel Drops were associated with significantly better corneal staining scores versus Refresh Liquigel eye drops in patients with dry eye. Supportive efficacy outcomes were not significantly different between groups. Both treatments were well tolerated.

Keywords: Refresh Liquigel; Systane Gel Drops; artificial tears; corneal staining; patient-reported outcomes.

Figures

Figure 1
Figure 1
Mean ± standard deviation NaFl corneal staining scores across visits. Abbreviations: CMC eye drops, carboxymethylcellulose sodium 1% eye drops; NaFl, sodium fluorescein; PEG eye drops, polyethylene glycol 0.4%, propylene glycol 0.3% eye drops.
Figure 2
Figure 2
Mean ± standard deviation change in NaFl corneal staining scores from baseline to the week 6 visit. Abbreviations: CMC eye drops, carboxymethylcellulose sodium 1% eye drops; NaFl, sodium fluorescein; PEG eye drops, polyethylene glycol 0.4%, propylene glycol 0.3% eye drops.
Figure 3
Figure 3
Mean ± standard deviation conjunctival staining scores across visits. Abbreviations: CMC eye drops, carboxymethylcellulose sodium 1% eye drops; PEG eye drops, polyethylene glycol 0.4%, propylene glycol 0.3% eye drops.
Figure 4
Figure 4
Mean ± standard deviation NaFl tear film break-up time across visits. Abbreviations: CMC eye drops, carboxymethylcellulose sodium 1% eye drops; NaFl, sodium fluorescein; PEG eye drops, polyethylene glycol 0.4%, propylene glycol 0.3% eye drops; s, seconds; TFBUT, tear film break-up time.

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