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Purpose: To evaluate the prevalence of dry eye disease (DED) in patients with both limited and diffuse subtypes of systemic sclerosis (SSc) and to determine the predictive factors associated with the occurrence of DED. Patients and Methods: This was a prospective consecutive cross-sectional study of patients with SSc. Each patient underwent a comprehensive ophthalmological evaluation. The Ocular Surface Disease Index (OSDI) was used to assess the symptoms of DED. Tear break up time (TBUT), Schirmer I and ocular surface staining (OSS) were used for objective tests. Patients were diagnosed DED using the DEW II diagnostic method which included both symptom and objective tests. The collected data of patients with and without DED were compared to find out possible associated factors. Logistic regression analysis was used to determine the effects of these factors. Results: Eighty-four SSc patients (25 limited and 59 diffuse subtypes) were studied. The prevalence of DED in SSc patients was 52.38%. The OSDI, tear break up time (TBUT), Schirmer I and ocular surface staining (OSS) were not significantly different between SSc subtypes. Among the 46 symptomatic patients, DED was noted in 44 (52.38%). Most patients (61.4%) were mixed aqueous deficiency-evaporative dry eye type (both TBUT and Schirmer I test positive). The mean age and the median of disease duration in DED patients were higher than those without DED with statistically significant difference (P = 0.004 and 0.019). Conclusion: DED was common in patients with SSc. The predictors for the occurrence of DED were older age and longer disease duration. Therefore, OSDI and objective tests for DED should be evaluated in all SSc patients, particularly those with older age and longer disease duration. [ABSTRACT FROM AUTHOR]