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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT00134992
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects of either gender, 18 years or older, who were able to give an informed consent
* A score for ocular discomfort of 0-20 mm on the visual analogue scale (VAS) prior to treatment
Exclusion Criteria:
* Known hypersensitivity to any of the constituents of the medications
* Known corticosteroid responder (elevation of intraocular pressure \[IOP\])
* Known allergic disposition (e.g. hay fever)
* Need of ocular antiallergic treatment
* Wearing of contact lenses
* Any kind of current eye disease (e.g. dry eye)
* Any kind of concomitant ocular treatment
* Any injury or infection in either eye during the last 3 months prior to the first application
* Any medication taken within the last 28 days prior to the first application, except hormonal contraceptives
* Concomitant or previous treatment with antihistamines within a week prior to enrolment
* Pregnant or breast feeding women
* Participation in another clinical study within 4 weeks prior to enrolment
* Hematological diseases such as aplastic anemia, panmyelopathy, or hemolytic icterus; with severe dysfunction of the liver.
* Any medical or laboratory condition which, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial per protocol
* Subjects with history of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastases exist, are excluded, with the exception of localized basal cell carcinoma of the skin
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00134992
Study Brief:
Protocol Section:
NCT00134992