IRCT201012265467N.
| Trial name or title |
Public title: the impact of omega‐3 on dry eye Scientific title: the impact of omega‐3 fatty acids supplements on dry eye |
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): not reported Number randomized (total and per group): 42 participants 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 40 and 65 years (planned) Gender: both (planned) Inclusion criteria: subjects with tear break up time of less than 10 seconds Exclusion criteria: subjects with blood coagulation problems and those who take blood thinning medications such as warfarin or Coumadin; subject with the history of stomach ulcer, hemorrhage, or surgery in the past three months; history of allergies to fish oil or gelatinous capsules. Equivalence of baseline characteristics? (Y/N): not reported |
| Interventions |
Intervention #1: omega‐3 capsule twice daily Intervention #2 (control): placebo gelatinous capsule twice daily Length of follow‐up: 1 month Notes: none |
| Outcomes |
Primary outcome(s): OSDI; TBUT; Schimer test Secondary outcome(s): not listed Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed): baseline; 1 month Other issues with outcome assessment (eg, quality control for outcomes, if any): none |
| Starting date | April 2012 |
| Contact information | Dr. Haleh Kangari College of Rehabilitation Corner of Bakhshifard Street, Damavand Ave. , Emam Hossein Square 1616913111, Tehran, Iran (Islamic Republic of) |
| Notes |
Date of last participant enrollment: not reported Date clinical trial registry last updated: February 22, 2018 Recruitment status: completed Actual completion date: not reported, but completed Other notes: study sponsored by Shahid Beheshti University of Medical Sciences |