CEQUA™ showed significant improvement in different dry eye outcome measures1-3
CEQUA was studied in two 12-week, randomized, vehicle-controlled
trials1
View the study design
Significant improvement in tear production at 3 months1
A higher proportion of eyes demonstrated significant improvement (≥10 mm) from baseline in Schirmer score with CEQUA vs vehicle1
Study 1
16.8% vs 8.6%
P<0.01
Study 2
16.6% vs 9.2%
P<0.01
Patients treated with CEQUA produced more tears2
Across 2 studies, patients treated with CEQUA produced approximately 2-3 mm more tears compared with patients treated with vehicle (Study 1, 3.5 mm vs 0.4 mm; Study 2, 2.80 mm vs 0.99 mm)
Significant improvement in total conjunctival staining2,3
- Study 1 found similar results at Day 84 (mean reduction from baseline: -1.9 vs -1.4 with vehicle, P<0.05)2
Read the published journal articles that evaluated the safety and efficacy of CEQUA:
Significant reduction in central and total corneal staining2,3
Central corneal staining
- At baseline, only 38.3% and 37.5% had complete clearing with CEQUA and vehicle, respectively2
Total corneal staining
- Study 1 found similar results at Days 28 and 842
- Day 28: Mean reduction from baseline: -1.1 vs -0.5 with vehicle, P<0.05
- Day 84: Mean reduction from baseline: -1.7 vs -0.9 with vehicle, P<0.01
Study design: CEQUA™ was studied in two 12-week, randomized, multicenter, double-masked, vehicle-controlled studies. Patients were randomly assigned to treatment and dosed twice a day. Study 1 included 455 patients (152 received CEQUA) and Study 2 included 744 patients (371 received CEQUA). The co-primary endpoints for Study 1 were conjunctival staining and global symptom scores (change from baseline to Day 84). The primary endpoint for Study 2 was percentage of eyes demonstrating an improvement of ≥10 mm in Schirmer score after 84 days of treatment. Both studies assessed corneal staining as a secondary endpoint.
Staining in each region of the conjunctiva was evaluated using a score ranging from 0 (no staining) to 3 (severe staining). Staining in each region of the cornea was evaluated using a score ranging from 0 (no staining) to 4 (severe staining).
Patients were excluded from the studies if they experienced prior treatment failure with cyclosporine 0.05% or used the therapy within 3 months prior to screening. Use of artificial tears was not allowed during the studies. The mean age was 59 years (range, 18-90 years). Eighty-three percent of patients were female.1-3