Why carry out this study? |
Diquafosol (DQS), a P2Y2 receptor agonist, is clinically proven to improve the signs and symptoms of dry eye disease (DED). |
Intense pulsed light (IPL) is an effective therapy for dermatological conditions. However, it was serendipitously discovered to improve evaporative dry eye and meibomian gland dysfunction in patients. |
The aim of this study was to explore the synergetic effects of 3% DQS ophthalmic solution and IPL therapy on the objective and subjective ocular surface dry eye parameters in patients with DED. |
What was learned from the study? |
During the follow-up period and final 28 days of the clinical study, no serious adverse events (AEs) were reported in all participants with IPL combined with DQS; furthermore, significant improvements in subjective and objective dry eye symptoms were found in these patients. |
The synergetic effects of 3% DQS ophthalmic solution with IPL therapy were found to be significantly better subjectively and objectively in comparison with IPL-only therapy. |
Introduction
Methods
Study Design
Inclusion and Exclusion Criteria
Treatment
Experimental Design
Clinical Assessment
Primary Outcome Measures
Secondary Outcome Measures
Statistical Analysis
Results
Patient Disposition
IPL + DQS | IPL-only | Sham IPL | p-value | |
---|---|---|---|---|
Number of participants (eyes) | 22 (44 eyes) | 22 (44 eyes) | 22 (44 eyes) | – |
Age, mean ± SD (years) | 32.70 ± 7.64 | 32.23 ± 7.29 | 32.26 ± 6.67 | 0.509 |
Sex, female (%) | 12 (54%) | 11 (52%) | 9 (50%) | > 0.05 |
Efficacy Evaluation
IPL + DQS (44 eyes) | IPL-only (44 eyes) | Sham (44 eyes) | p-Value2 | |
---|---|---|---|---|
NITBUT(s) | ||||
D0 | 4.98 ± 0.36 | 4.60 ± 0.48 | 4.74 ± 0.45 | 0.323 |
D14 | 10.44 ± 1.68 | 7.97 ± 1.91 | 3.78 ± 0.42 | < 0.001* |
D28 | 12.03 ± 1.27 | 10.47 ± 3.48 | 4.57 ± 0.46 | < 0.001* |
p-Value1 | < 0.001* | < 0.001* | 0.323 | |
Δ | −7.43 | −5.88 | 0.85 | |
TFLL (1–5) | ||||
D0 | 2.70 ± 0.59 | 2.80 ± 0.48 | 2.82 ± 0.66 | 0.099 |
D14 | 2.32 ± 0.47 | 2.55 ± 0.63 | 2.98 ± 0.63 | < 0.001* |
D28 | 2.09 ± 0.29 | 2.27 ± 0.45 | 2.89 ± 0.65 | < 0.001* |
p value1 | < 0.001* | < 0.001* | 0.106 | |
Δ | 0.61 | 0.52 | −0.05 | |
CS (0–9) | ||||
D0 | 2.84 ± 1.55 | 2.95 ± 1.57 | 3.27 ± 1.40 | 0.075 |
D14 | 2.23 ± 1.01 | 2.80 ± 1.52 | 3.57 ± 1.00 | < 0.001* |
D28 | 1.43 ± 0.82 | 1.93 ± 1.32 | 3.52 ± 1.00 | < 0.001* |
p-Value1 | < 0.001* | < 0.001* | 0.070 | |
Δ | 1.41 | 1.02 | −0.25 | |
MGQ (1–4) | ||||
D0 | 2.57 ± 0.59 | 2.59 ± 0.58 | 2.57 ± 0.55 | 0.916 |
D14 | 1.77 ± 0.60 | 2.00 ± 0.72 | 2.61 ± 0.54 | < 0.001* |
D28 | 1.55 ± 0.66 | 1.91 ± 0.77 | 2.66 ± 0.53 | < 0.001* |
p value1 | < 0.001* | < 0.001* | 0.135 | |
Δ | 0.970 | 0.690 | −0.090 | |
MGEx (1–4) | ||||
D0 | 2.41 ± 0.50 | 2.48 ± 0.51 | 2.36 ± 0.49 | 0.390 |
D14 | 1.66 ± 0.57 | 2.02 ± 0.63 | 2.39 ± 0.49 | < 0.001* |
D28 | 1.27 ± 0.45 | 1.75 ± 0.44 | 2.41 ± 0.50 | < 0.001* |
p-Value1 | < 0.001* | < 0.001* | 0.376 | |
Δ | 1.13 | 0.74 | −0.05 | |
OSDI Score (0–100) | ||||
D0 | 43.57 ± 10.20 | 42.97 ± 8.78 | 42.36 ± 7.10 | 0.596 |
D14 | 21.68 ± 7.65 | 30.00 ± 4.27 | 42.55 ± 7.39 | < 0.001* |
D28 | 19.36 ± 7.01 | 24.77 ± 4.68 | 42.61 ± 7.49 | < 0.001* |
p value1 | < 0.001* | < 0.001* | 0.300 | |
Δ | 24.20 | 18.91 | −0.25 |