NCT02908282.
| Trial name or title | Topical omega‐3 fatty acids (REMOGEN OMEGA) in the treatment of dry eye (REMOTOP) |
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center (5 sites) Number randomized (total and per group): 100 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: Germany Age (mean ± SD, range): not reported Gender: both sexes eligible to participate Inclusion criteria: 1. Male or female patient between 18 and 80 years of age and in good general health 2. Signed written informed consent 3. Existence of moderate to severe DES symptoms defined as break‐up time (TBUT) ≤ 10 s (mean of 3 consecutive measurements) and OSDI questionnaire score ≥ 20 Exclusion criteria: 1. Contraindication for the use of products (eg, hypersensitivity to constituents of the test products) or any study procedure 2. Concomitant or previous participation in a clinical investigation within the last 3 months 3. Concomitant therapies/manipulations that affect the tear film, tear secretion, or ocular surface integrity or would alter the effects of the devices being evaluated 4. Concurrent (systemic) DES‐associated diseases that are not on a stable therapy for at least 1 month (therapy not expected to change) 5. Glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected to change) 6. Any diseases or characteristics judged by the investigator to be incompatible with assessments and/or procedures for the study evaluation 7. Pregnant or lactating females 8. Participants of child‐bearing age who do not use adequate methods of birth control 9. Subjects unable to understand informed consent or having a high probability of non‐compliance with study procedures and/or non‐completion of the study according to investigator's judgement (eg, illiteracy, insufficient knowledge of local language) 10. Subjects not capable of contracting and of understanding the nature, risks, significance, and implications of the clinical investigation, and unable to form a rational intention in the light of these facts Equivalence of baseline characteristics? (Y/N): not reported |
| Interventions |
Intervention #1: REMOGEN OMEGA lubricant eye drops: preservative‐free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single‐dose containers of 0.25 mL Intervention #2 (control): povidone artificial tears: preservative‐free eye drops containing 2% povidone Length of follow‐up: 12 weeks Notes: topical omega‐3 intervention |
| Outcomes |
Primary outcome(s): OSDI and TBUT at week 4 Secondary outcome(s): OSDI (week 12), TBUT (week 12), best‐corrected visual acuity (weeks 4 and 12), tear osmolarity (weeks 4 and 12), MMP‐9 (weeks 4 and 12), lid parallel conjunctival folds (weeks 4 and 12), corneal staining ‐ Oxford scale (weeks 4 and 12), tear volume ‐ Schirmer test (weeks 4 and 12), and conjunctival staining ‐ Oxford scale (weeks 4 and 12) Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): day 0, week 4, and week 12 Other issues with outcome assessment (eg, quality control for outcomes, if any): none |
| Starting date | Recruitment status: active, not recruiting (last updated: July 3, 2018) |
| Contact information | Thomas Kaercher, MD Heidelberg, Baden‐Württemberg, Germany, 69121 |
| Notes | Other notes: sponsored by TRB Chemedica AG (industry) |