Management of Moderate-to-Severe Dry Eye Disease: Topical Cyclosporine vs. Lifitegrast
Introduction
Dry eye disease (DED) is a chronic, multifactorial ocular surface condition and a serious public health issue. Dry eye disease significantly impairs the quality of life and ocular health of the affected individual. Topical anti-inflammatory therapy is the cornerstone in the management of mild-to-moderate DED. Immunomodulatory agents such as cyclosporine and lifitegrast have been used widely in DED patients. Nevertheless, there is dearth of comparative evidence on the efficacy and tolerability of these two agents.
Aim
To compare the efficacy and safety of topical cyclosporine A 0.05% vs. lifitegrast 5% in the management of moderate-to-severe DED.
Patient Profile
- Patients clinically diagnosed with moderate-to-severe DED (age;18-75 years, n=110)
- Diagnosis of moderate-to-severe DED was based on Tear Film Break-Up Time (TBUT) ≤ 10 seconds, Schirmer’s I test ≤ 10 mm/5 min, and Ocular Surface Disease Index (OSDI) score ≥ 23
- Patients reported presence of symptoms such as foreign body sensation, dryness, burning, or blurred vision for at least 3 months
Methods
Study Design
- A prospective, randomized, comparative study.
Treatment Strategy
- The study population was randomized into two groups as follows:
- Group A: Treated with cyclosporine A 0.05%, administered twice daily for 12 weeks.
- Group B: Treated with lifitegrast 5%, administered twice daily for 12 weeks.
Assessments
- OSDI scores, Schirmer’s test, TBUT, and fluorescein staining were assessed at baseline and at follow-up visits conducted at weeks 4, 8, and 12.
Outcomes
Primary Outcome
- Change in OSDI score from baseline to the end of 12 weeks
Secondary Outcomes
- Changes in Schirmer’s test values, TBUT, and fluorescein staining scores across the 12-week treatment period.
- Treatment tolerability and incidence of adverse effects.
Results
- Mean age of the study population was 52.1 years and 51.7 years in groups A and B, respectively. Female patients predominated in both groups (group A: 65.45%, group B: 69.09%)
- Both groups were comparable at baseline in terms of symptom duration, and DED severity.
- Patients treated with lifitegrast had a significantly greater reduction in OSDI scores at week 12, as compared to those treated with cyclosporine (p < 0.001) (Fig. 1).
Fig. 1: Changes in the OSDI score during the study period
- Patients treated with lifitegrast had greater improvements in the Schirmer’s test, as compared to those treated with cyclosporine. Similarly, the improvement in TBUT was greater in those treated with lifitegrast vs. cyclosporine (Table 1).
Table 1: Improvement in the secondary outcomes during the study period
|
Time point |
Group A (Mean ± SD) |
Group B (Mean ± SD) |
p-value |
|
Schirmer’s Test Scores (mm) Over 12 Weeks |
|||
|
Baseline |
5.3 ± 1.2 |
5.4 ± 1.1 |
0.695 |
|
Week 4 |
7.1 ± 1.3 |
7.8 ± 1.4 |
0.010 |
|
Week 8 |
8.9 ± 1.5 |
9.6 ± 1.3 |
0.007 |
|
Week 12 |
10.2 ± 1.4 |
11.1 ± 1.5 |
0.002 |
|
TBUT (Tear Film Break-Up Time in seconds) |
|||
|
Baseline |
6.4 ± 1.1 |
6.5 ± 1.2 |
0.721 |
|
Week 4 |
8.1 ± 1.0 |
8.6 ± 1.1 |
0.032 |
|
Week 8 |
9.3 ± 1.2 |
10.1 ± 1.3 |
0.006 |
|
Week 12 |
10.5 ± 1.1 |
11.4 ± 1.2 |
0.001 |
- Both medications were well tolerated; nevertheless, burning sensation was more frequently reported by patients treated with cyclosporine (21.82% vs. 14.55%). Treatment compliance was high in both the study groups (>90%).
Conclusions
- Topical cyclosporine and lifitegrast both improved symptoms and clinical outcomes in moderate-to-severe DED.
- Lifitegrast provided quicker relief, enhanced tear production and stability, and showed slightly better tolerability, supporting its role as a preferred first-line therapy for patients needing rapid response.
- Cyclosporine remains an important option for sustained long-term management.
Int J Life Sci Biotechnol Pharma Res.
