IRCT20181028041487N1.

Trial name or title	Public title: evaluation the effect of intra nasal viola odorata almond oil drop on dry eye disease Scientific title: evaluation the effect of intra nasal viola odorata almond oil drop on dry eye disease
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): not reported Number randomized (total and per group): 60 participants (planned) Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Participant characteristics Country: Iran Age (mean ± SD, range): age between 30 to 70 years Gender: both (planned) Inclusion criteria: age between 30 to 70 years; Tear Break Up Time less than 10 seconds at least in one eye; Schirmer test less than 10 millimeter at least in one eye without Local anesthesia; 2 symptoms of feeling eye dryness, foreign body sensation, eye burning Exclusion criteria: any active eye infection; pregnancy or lactation; any anatomic disorder like entropion or ectropion; incoordination of patients; important surface diseases of eyes which affects test results; history of eye trauma during the past 2 months; moderate to severe blepharitis; refraction surgery or laser therapy of eyes during the past month
Interventions	Intervention #1: daily treatment with artificial tear and viola odorata almond oil drop intranasal 2 drops in each nostril at night before sleeping category Intervention #2 (control): daily treatment with artificial tear and normal saline drop intranasal 2 drops in each nostril at night before sleeping Length of follow‐up: 6 weeks Notes: none Equivalence of baseline characteristics? (Y/N): not reported
Outcomes	Primary outcome(s): eye dryness based on the score of questionnaire Secondary outcome(s): not listed Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed): not reported Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	January 2018
Contact information	Dr Ali Davati Shahed University Beginning of Tehran Qom freeway‐Shahed university, 33191‐18651, Tehran, Iran (Islamic Republic of)
Notes	Date of last participant enrollment: February 19, 2019 (recruitment) Date clinical trial registry last updated: January 28, 2019 Recruitment status: completed Other notes: study sponsored by Shahed University