Status:
COMPLETED
Evaluation of Safety and Efficacy of PDP-716
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
Eligibility Criteria
Inclusion
- Be male or female, of 2 years of age or older
- Have open-angle glaucoma or ocular hypertension in both the eyes
- Be able and willing to follow study instructions and complete all required visits.
Exclusion
- Females who are pregnant/lactating.
- Have uncontrolled systemic disease which might interfere with the study
- Any known allergy or sensitivity to the study medications or their components
- Any other clinically relevant abnormality
Key Trial Info
Start Date :
September 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
682 Patients enrolled
Trial Details
Trial ID
NCT03450629
Start Date
September 13 2018
End Date
December 1 2020
Last Update
February 15 2022
Active Locations (47)
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1
SPARC Site 4
Chandler, Arizona, United States, 85225
2
SPARC Site 5
Prescott, Arizona, United States, 86301
3
SPARC Site 3
Sun City, Arizona, United States, 85351
4
SPARC Site 38
Burbank, California, United States, 91506