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Table 1 Summary of Randomized controlled clinical trials in the ocular treatment of ocular complications of Sjögren’s syndrome

From: Systematic review of randomized controlled trials in the treatment of dry eye disease in Sjogren 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
  1. aAll participants in these studies from single center except Hu et al., which is multi-center study
  2. BCL Bandage contact lens
  3. CFS Corneal fluorescein staining
  4. CsA Cyclosporin A
  5. FML Fluoromethalone
  6. LGS Lissamine green stain
  7. NSAIDs Non-steroidal anti-inflammatory drugs
  8. OSDI Ocular surface disease index
  9. PEG Polyethylene glycol
  10. PVP Polyvinylpyrrolidone
  11. TBUT Tear break up time
  12. VAS Visual analogue scale
  13. DQS Diquafosol sodium
  14. TMR Tear meniscus radius curvature