IRCT20180806040722N1.
| Trial name or title |
Public title: effect of complementary supplementation Camelina Oil on the improvement of dry eye disease in patients with dry eye Scientific title: effect of complementary supplementation Camelina Oil on the improvement of dry eye disease in patients with dry eye |
| 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): between 18 and 65 years (planned) Gender: both (planned) Inclusion criteria: patients with moderate dry eye; ability to take oral capsules; fill in the consent form; ability to visit for examination Exclusion criteria: eye Schirmer test less than 5 mm; TBUT eyes less than 5 seconds; excessive corneal opacification; the presence of corneal ulcer at least in that eye; pregnancy or breastfeeding; corticosteroid use or systemic anti‐inflammatory treatment simultaneously; taking any oral supplement; a clear change in diet during the last month or during treatment; any eye surgery over the past 6 months in the affected eye Equivalence of baseline characteristics? (Y/N): not reported |
| Interventions |
Intervention #1: capsule containing paraffin oil, two grams, twice a day accompanied by breakfast and lunch Intervention #2 (control): capsule containing Comelina oil, 2 grams, twice a day accompanied by breakfast and lunch Length of follow‐up: 3 months Notes: none |
| Outcomes |
Primary outcome(s): Schirmer test; TBUT 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 | November 2018 |
| Contact information | Mahdieh Reyhani Tabriz University of Medical Sciences Hospital Bina,Tehran, 1786521, Tehran, Iran (Islamic Republic of) |
| Notes |
Date of last participant enrollment : recruitment pending Date clinical trial registry last updated: May 21, 2019 Recruitment status: pending Other notes: study sponsored by Tabriz University of Medical Sciences |