Demiryay 2011.

Methods	Study design: parallel‐group randomized controlled trial Number randomized: total: 42 eyes of 42 participants; topical CsA: 22 eyes of 22 participants, artificial tears: 20 eyes of 20 participants Exclusions after randomization: none Losses to follow‐up: none Number analyzed (total and per group): total: 42 eyes of 42 participants; topical CsA: 22 eyes of 22 participants, artificial tears: 20 eyes of 20 participants Unit of analysis: participant, both eyes included and 1 eye selected for analysis or both eyes averaged How were the missing data handled?: not applicable Power calculation: not reported
Participants	Country: not reported Age: mean ± SD: 45.5 ± 13.2, range: 17 to 66 years Sex: men: 2 (4.8%), women: 40 (95.2%) Inclusion criteria: Schirmer I (without anesthesia) scores below 10 mm/5 min; TBUT below 10s as defined for mild‐to‐severe patients with dysfunctional tear syndrome in the Dry Eye Workshop grading scheme Exclusion criteria: history of systemic or ocular diseases (including ocular surgery and trauma); use of ophthalmic or systemic medications (including artificial tears), and pregnancy Equivalence of baseline characteristics: yes
Interventions	Intervention 1: topical CsA 0.05% eye drops (Restasis, Allergan) twice daily plus preservative‐free artificial tears (0.3% hydroxypropyl methylcellulose/0.1% dextran 70 (Tears Naturale Free, Alcon)) 4 times daily for 4 months Intervention 2: artificial tear drops (Tears Naturale Free, Alcon) 4 times daily for 4 months Length of follow‐up: 4 months
Outcomes	Primary outcomes, as defined: primary outcomes were not specified Secondary outcomes: Ocular surface dye staining, as defined by the mean change in corneal fluorescein at 4 months follow‐up Ocular surface dye staining, as defined by the mean change in conjunctival lissamine green at 4 months follow‐up Aqueous tear production, as measured by the mean change in Schirmer test scores (millimeters) performed with or without anesthesia Change in conjunctival goblet cell density Tear film stability, as measured by the mean change in TBUT (seconds) Adverse events reported: "No ocular or systemic side effects were observed in any of the patients during the study" Intervals at which outcomes were assessed: 4 months
Notes	Study period: not reported Funding sources: not reported Declarations of interest: explicitly reported that none of the authors has any financial relationship Reported subgroup analyses: not reported Trial registration: not available
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomization was not reported.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"The patients were not masked to the therapy regimens"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"The investigators assessing the test scores were masked to the therapy regimens of the patients"
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data were reported.
Selective reporting (reporting bias)	Unclear risk	Protocol was not available.
Other bias	Low risk	None