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 |