Open Angle GlaucomaPhase 3NCT03450629
Evaluation of Safety and Efficacy of PDP-716
A Phase 3 study testing Brimonidine Tartrate Ophthalmic Suspension and Brimonidine Tartrate Ophthalmic Solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Sun Pharma Advanced Research Company Limited at 47 sites in United States.
Trial summary
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Brimonidine Tartrate Ophthalmic Suspension and Brimonidine Tartrate Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 47 sitesUnited States
- Study dates
- 13 Sep 2018to 1 Dec 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
SPARC Site 42
Atlanta, Georgia, 30349
SPARC Site 40
Bowie, Maryland, 20715
SPARC Site 38
Burbank, California, 91506
SPARC Site 4
Chandler, Arizona, 85225
SPARC Site 12
Chicago, Illinois, 60619
SPARC Site 37
Cincinnati, Ohio, 45242
SPARC Site 8
Cleveland, Ohio, 44115
SPARC Site 7
Colorado Springs, Colorado, 80919
SPARC Site 11
Coral Springs, Florida, 33067
SPARC Site 24
Cranberry Township, Pennsylvania, 16066
SPARC Site 29
Deerfield Beach, Florida, 33064
SPARC Site 33
Fargo, North Dakota, 58103
SPARC Site 34
Fort Myers, Florida, 33901
SPARC Site 30
Gastonia, North Carolina, 28054
SPARC Site 44
Glendale, California, 91204
SPARC Site 45
Glendale, California, 91204
SPARC Site 9
High Point, North Carolina, 27262
SPARC Site 46
Hollywood, Florida, 33021
SPARC Site 39
Houston, Texas, 77008
SPARC Site 21
Jacksonville, Florida, 32204
SPARC Site 28
Kansas City, Missouri, 64055
SPARC Site 48
Kansas City, Missouri, 64133
SPARC Site 32
Memphis, Tennessee, 38119
SPARC Site 35
Miami, Florida, 33126
SPARC Site 27
Miami, Florida, 33134
SPARC Site 10
Miami, Florida, 33143
SPARC Site 16
Miami, Florida, 33145
SPARC Site 19
Miami, Florida, 33174
SPARC Site 25
Miami, Florida, 33175
SPARC Site 13
Mission, Texas, 78572
SPARC Site 43
Mission Hills, California, 91345
SPARC Site 2
Morrow, Georgia, 30260
SPARC Site 1
Newport Beach, California, 92663
SPARC Site 23
Paducah, Kentucky, 42001
SPARC Site 41
Pompano Beach, Florida, 33060
SPARC Site 15
Poughkeepsie, New York, 12603
SPARC Site 5
Prescott, Arizona, 86301
SPARC Site 36
Rochester, New York, 14618
SPARC Site 22
Roswell, Georgia, 30076
SPARC Site 26
Saint Albans, Vermont, 05478
SPARC Site 20
San Antonio, Texas, 78215
SPARC Site 14
Santa Barbara, California, 93110
SPARC Site 31
St Louis, Missouri, 63128
SPARC Site 3
Sun City, Arizona, 85351
SPARC Site 18
Tampa, Florida, 33603
SPARC Site 47
Torrance, California, 90505
SPARC Site 17
Winston-Salem, North Carolina, 27101
About this study
Official title: A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Brimonidine Tartrate Ophthalmic Suspension, Brimonidine Tartrate Ophthalmic Solution
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine Tartrate Ophthalmic SuspensionDrug
PDP-716
Brimonidine Tartrate Ophthalmic SolutionDrug
Three Times Brimonidine Tartrate Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| PDP-716 | Experimental | Not described Receives: Drug: Brimonidine Tartrate Ophthalmic Suspension |
| Brimonidine Tartrate Ophthalmic Solution | Active comparator | Not described Receives: Drug: Brimonidine Tartrate Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Intraocular Pressure
Measured: Week 12 8 AM, 10 AM and 4 PM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start13 Sep 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450629
- Sponsor's protocol ID
- CLR_16_33
- Status last verified
- Jan 2022
- First submitted
- 21 Feb 2018
- Last updated
- 15 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT03450629
- Acronym / sponsor ID
- CLR_16_33
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Posted 15 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDP-716 | Experimental | Drug: Brimonidine Tartrate Ophthalmic Suspension |
| Brimonidine Tartrate Ophthalmic Solution | Active comparator | Drug: Brimonidine Tartrate Ophthalmic Solution |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brimonidine Tartrate Ophthalmic SuspensionPDP-716 | Drug | PDP-716 |
| Brimonidine Tartrate Ophthalmic SolutionThree Times Brimonidine Tartrate Ophthalmic Solution | Drug | Brimonidine Tartrate Ophthalmic Solution |
Primary outcome
Change From Baseline in Mean Intraocular Pressure
Time frame: Week 12 8 AM, 10 AM and 4 PM
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brimonidine Tartrate Ophthalmic Suspension and Brimonidine Tartrate Ophthalmic Solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Sun Pharma Advanced Research Company Limited at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Intraocular Pressure (time frame: Week 12 8 AM, 10 AM and 4 PM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.