Evaluation of Safety and Efficacy of PDP-716

Phase 3

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Brimonidine Tartrate Ophthalmic Suspension; Drug: Brimonidine Tartrate Ophthalmic Solution

• Registration Number: NCT03450629
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-01
• Study Start: 2018-09-13
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Results First Submitted: 2021-11-30
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Results First Posted: 2022-02-15
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 682

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDP-716	Brimonidine Tartrate Ophthalmic Suspension	-
Brimonidine Tartrate Ophthalmic Solution	Brimonidine Tartrate Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Intraocular Pressure	Week 12 8 AM, 10 AM and 4 PM

Trial Locations

Locations (47)

SPARC Site 4; 🇺🇸 Chandler, Arizona, United States

SPARC Site 5; 🇺🇸 Prescott, Arizona, United States

SPARC Site 3; 🇺🇸 Sun City, Arizona, United States

SPARC Site 38; 🇺🇸 Burbank, California, United States

SPARC Site 44; 🇺🇸 Glendale, California, United States

SPARC Site 45; 🇺🇸 Glendale, California, United States

SPARC Site 43; 🇺🇸 Mission Hills, California, United States

SPARC Site 1; 🇺🇸 Newport Beach, California, United States

SPARC Site 14; 🇺🇸 Santa Barbara, California, United States

SPARC Site 47; 🇺🇸 Torrance, California, United States

Scroll for more (37 remaining)