Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01630551
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
* OSDI score \> 12
* Schirmer Test with Anesthesia \< 8 mm/5 minutes
* Fluorescein tear break-up time \< 8 seconds
* No current use of dry eye treatment (except artificial lubrication)
Exclusion Criteria:
* Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye or topical glaucoma medication use
* Patients with severe tear deficiency (defined as Schirmer tes \<5 mm/5 min)
* Concomitant ocular pathology
* History of ocular surgery
* Eyelid or eyelash abnormalities
* Alteration of the nasolacrimal apparatus
* Treatment with drugs affecting tearing
* Treatment with vitamin supplements
* Concomitant ocular therapies
* Topical ophthalmic steroids taken during the 4 weeks before the study
* Pregnant/breast-feeding women
* Women who may be pregnant at the baseline visit or may become pregnant during the 90 days of therapy
* Diabetes
* History of fish and/or shellfish allergy or hypersensitivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01630551
Study Brief:
Protocol Section:
NCT01630551