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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT02734459
Eligibility Criteria:
Inclusion Criteria:
* Be male or female 18 years of age and above
* Presence of visually significant cataracts in both eyes
* Have a chief complaint consistent with visually significant cataracts
* Be able to communicate effectively with the study personnel and be able to understand and follow directions
* Be medically fit with clinically acceptable laboratory profiles and ECG
* Be willing to carry out the required pre op directions and post op care and be able to make the scheduled appointment
* Have given the written informed consent for participation in the study
* In addition, female patients of child bearing potential age must have a negative urine pregnancy test
Exclusion Criteria:
* Participation in any ophthalmic indicative bioavailability/ bioequivalence/ Pharmacokinetic study or received an ophthalmic indicative investigational drug within a period of three months prior to screening
* Presence or history of recent viral corneal disorder or active corneal condition which is contraindicated.
* Presence or history of uveitis or uveitis
* Presence of retinal disorders
* Ocular trauma within three months of the trial
* Patients who had received topical and or systemic/ oral steroids
* Uncontrolled diabetes
* History of any allergies
* Known hypersensitivity or allergy to TobraDex® in combination or its components
* Clinical laboratory test values outside the acceptable reference range and when confirmed on re-examination deemed to be clinically significant as determined by the investigator(s)
* Clinically significant illness during 3 weeks prior to Visit 1 (as determined by the investigators)
* Presence of a clinically significant systemic disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02734459
Study Brief:
Protocol Section:
NCT02734459