Trial · NCT03450629

Evaluation of Safety and Efficacy of PDP-716

NCT03450629, Phase 3, Completed, Sun Pharma Advanced Research Company Limited; results first posted 2022-02-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Safety and Efficacy of PDP-716. Trials, record NCT03450629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03450629

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of Safety and Efficacy of PDP-716
NCT number: NCT03450629
Status: Completed
Phases: Phase 3
Enrollment: 682 participants, actual
Lead sponsor: Sun Pharma Advanced Research Company Limited
Conditions: Open Angle Glaucoma, Ocular Hypertension
Interventions: Brimonidine Tartrate Ophthalmic Suspension, Brimonidine Tartrate Ophthalmic Solution
First posted: 2018-03-01
Last updated: 2022-02-15
Results first posted: 2022-02-15

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Mean Intraocular Pressure	Week 12 8 AM, 10 AM and 4 PM

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Mean Intraocular Pressure	Week 12 8 AM, 10 AM and 4 PM	Per-Protocol Population	mmHg	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Mean Intraocular Pressure	PDP-716	8 AM +/- 30 min	20.35	Standard Deviation 3.746	mmHg
Change From Baseline in Mean Intraocular Pressure	Brimonidine Tartrate Ophthalmic Solution	8 AM +/- 30 min	20.79	Standard Deviation 3.724	mmHg
Change From Baseline in Mean Intraocular Pressure	PDP-716	10 AM +/- 30 min	17.38	Standard Deviation 3.401	mmHg
Change From Baseline in Mean Intraocular Pressure	Brimonidine Tartrate Ophthalmic Solution	10 AM +/- 30 min	18.31	Standard Deviation 18.31	mmHg
Change From Baseline in Mean Intraocular Pressure	PDP-716	4 PM +/- 30 min	17.99	Standard Deviation 3.309	mmHg
Change From Baseline in Mean Intraocular Pressure	Brimonidine Tartrate Ophthalmic Solution	4 PM +/- 30 min	17.57	Standard Deviation 3.579	mmHg

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PDP-716	341
Overall Study	STARTED	Brimonidine Tartrate Ophthalmic Solution	341
Overall Study	COMPLETED	PDP-716	293
Overall Study	COMPLETED	Brimonidine Tartrate Ophthalmic Solution	307
Overall Study	NOT COMPLETED	PDP-716	48
Overall Study	NOT COMPLETED	Brimonidine Tartrate Ophthalmic Solution	34

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Somnolence	Nervous system disorders	PDP-716	32	337	32
other	Somnolence	Nervous system disorders	Brimonidine Tartrate Ophthalmic Solution	21	341	21
other	Conjunctival hyperaemia	Eye disorders	PDP-716	8	337	8
other	Conjunctival hyperaemia	Eye disorders	Brimonidine Tartrate Ophthalmic Solution	6	341	6
other	Conjunctivitis	Infections and infestations	PDP-716	15	337	15
other	Conjunctivitis	Infections and infestations	Brimonidine Tartrate Ophthalmic Solution	11	341	11
other	Vision blurred	Eye disorders	PDP-716	9	337	9
other	Vision blurred	Eye disorders	Brimonidine Tartrate Ophthalmic Solution	0	341	0
serious	Appendicitis	Infections and infestations	PDP-716	1	337	1
serious	Appendicitis	Infections and infestations	Brimonidine Tartrate Ophthalmic Solution	0	341	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PDP-716	0	337
Total, all-cause mortality	Brimonidine Tartrate Ophthalmic Solution	0	341
Total, other adverse events	PDP-716	63	337
Total, other adverse events	Brimonidine Tartrate Ophthalmic Solution	38	341
Total, serious adverse events	PDP-716	1	337
Total, serious adverse events	Brimonidine Tartrate Ophthalmic Solution	3	341

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
PDP-716 vs Brimonidine Tartrate Ophthalmic Solution: deaths from any cause	Trial comparisons
PDP-716 vs Brimonidine Tartrate Ophthalmic Solution: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03450629

GET https://conductscience.org/api/trials/v1/NCT03450629/registered

API reference For AI assistants