Table 1 Summary of Randomized controlled clinical trials in the ocular treatment of ocular complications of Sjögren’s syndrome
| Participantsa | Intervention | Study arms | Duration | Ocular Efficacy Outcomes | Significant findings | Potential bias/ limitation | |
|---|---|---|---|---|---|---|---|
| Lin, T. and L. Gong (2015) |
40 patients Group i (20) Group ii (20) |
Topical 0.1% FML eye drops 4 times daily |
i. 0.1% FML + 0.1% HA ii. 0.5% CsA + 0.1% HA | 8 weeks |
• OSDI • CFS • Conjunctival goblet cell density • Schirmer I • TBUT | i provided faster improvement than ii evidenced in CFS, OSDI and conjunctival congestion with statistical significance |
• Small sample size • Short duration • Open label design |
| Aragona, P., et al. (2013) |
40 patients Group i. (20) Group ii (20) |
Topical 0.1% Clobetasone butyrate eye drops 2 times daily |
i. 0.1% clobetasone butyrate eyedrop BD + 2% PVP ii. PEG +2% PVP | 30 days |
• Dry eye symptoms (VAS) • CFS • LGS • TBUT | i showed improvement in symptoms, CFS and conjunctival stain compared to group ii |
• Short study period • Small sample size • No mention of drop out rates. |
| Moscovici, B. K., et al. (2015) |
24 patients Group i (14) Group ii (10) | Topical Tacrolimus eye drops 0.03% every 12 h |
i. Tacrolimus 0.03% ii. Almond oil placebo | 90 days |
• CFS • Rose Bengal stain • Schirmer I • TBUT | Rose Bengal stain (P = 0.007) and CFS (P = 0.008) improved. |
• Small sample size • No symptom-based analysis |
| Noble, B. A., et al. (2004) | 16 patients |
Topical 50% Autologous serum eye drops 1 bottle daily |
Cross-over study Autologous serum 50% (3 months), Lubricant (3 months) | 6 months |
• Dry eye symptoms (face score) • CFS • Impression cytology • Rose Bengal stain • Schirmer I | Autologous serum is superior to conventional treatment for ocular surface (P < 0.02), and subjective comfort (P < 0.01) |
• Small sample size • No participant masking |
| Aragona, P., et al. (2005) |
20 patients Group i (10) Group ii (10) |
Topical NSAIDs eye drops 3 drops daily |
i. 0.1% indomethacin ii. 0.1% diclofenac | 30 days |
• Dry eye symptoms (0–3 scoring system) • CFS • Corneal sensitivity • TBUT | Groups i, ii: improved symptoms (day 15) (P = 0.01; P = 0.004); mproved corneal sensitivity (day 30) (P = 0.04; P = 0.005) |
• Small sample size • Short study period • Single blinded |
| Yokoi N., et al. (2016) | 17 patients | 3% DQS eye drop 1 drop |
i. 3% DQS eye drop in one eye ii. AT solution in the fellow eye | 15 min |
• Dry eye symptoms (VAS) • CFS • Schirmer I • TBUT • TMR | TMR and VAS score improved in DQS treated eyes at 15 min after instillation (P < 0.0001) and (P < 0.001). |
• Short study period • Small sample size |
| Li, J., et al. (2015) |
37 patients Group i (19) Group ii (18) | BCL daily, 3 weeks of continuous wear |
i. BCL ii. Autologous serum | 6 weeks |
• OSDI • CFS • Schirmer I • TBUT |
BCL has a lower OSDI than Autologous serum. (P < 0.001) BCL has less CFS than Autologous serum. (P < 0.01) |
• Small sample size • Not blinded • Short study period |
| Qiu, W., et al. (2013) |
40 patients Group i (21) Group ii (19) | Punctal Plugs |
i. Punctal plugs ii. Artificial tears | 3 months |
• OSDI • CFS • Schirmer I • TBUT | Schirmer I and TBUT improved in punctal plugs more than Artificial tears (P < 0.001) |
• Short study period • Small sample size |
| Mansour K., et al. (2007) | 13 patients | Punctal Plugs |
i. Punctal plugs ii. No intervention (on fellow eye) | 6–20 weeks |
• Dry eye symptoms (0–10 scoring system) • Rose Bengal stain • Schirmer I | Rose Bengal (P < 0.02) and dry eye symptoms (P < 0.01) improved in punctum-occluded eye. No change in Schirmer I. |
• Short study period • Small sample size • Not blinded |
