Evaluation of Safety and Efficacy of PDP-716

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Brimonidine Tartrate Ophthalmic Solution; Drug: Brimonidine Tartrate Ophthalmic Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT03450629

CLR_16_33

Details and patient eligibility

About

The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.

Enrollment: 682 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be male or female, of 2 years of age or older
2. Have open-angle glaucoma or ocular hypertension in both the eyes
3. Be able and willing to follow study instructions and complete all required visits.

Exclusion criteria

1. Females who are pregnant/lactating.
2. Have uncontrolled systemic disease which might interfere with the study
3. Any known allergy or sensitivity to the study medications or their components
4. Any other clinically relevant abnormality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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682 participants in 2 patient groups

PDP-716

Experimental group

Treatment:

Drug: Brimonidine Tartrate Ophthalmic Suspension

Brimonidine Tartrate Ophthalmic Solution

Active Comparator group

Treatment:

Drug: Brimonidine Tartrate Ophthalmic Solution