Primary Open Angle GlaucomaPhase 3NCT02059278
Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing T-2345 and Xalatan in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Nephron Pharmaceuticals Corporation at 1 site in United States.
Trial summary
This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84 days in patients with elevated eye pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- T-2345 and Xalatan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- POAG or OH with IOP treated and adequately controlled (IOP ≤ 18 mm Hg) with latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks prior to Screening.
- Each eye being treated with latanoprost 0.005% ophthalmic solution monotherapy must have mean IOP ≤ 18 mm Hg at Screening and mean IOP ≤ 28 mm Hg at Baseline; measurements will be taken at each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes) with AM measurements of IOP at least 2 hours apart. If only one eye qualifies but both eyes have glaucoma and the fellow eye will require antiglaucoma medications, the subject does not qualify for the trial.
- Stable visual field (VF), defined as no sign of VF degradation between two consecutive 30-2 or two consecutive 24-2 VF examinations. For subjects with no VF defect (eg, those with OH), a single, normal VF examination performed ˂ 6 months prior to the screening visit is allowed to determine eligibility. For patients who have an abnormal VF examination, the following criteria apply:
- Two VF (most recent VF and past VF) examinations performed at least ≥ 6 months and ≤ 18 months apart must be compared;
- The most recent VF examination should be performed < 6 months prior to the Screening visit;
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- The past VF examination should be performed ≥ 6 months and ≤ 18 months prior to the most recent VF test.
- Stable corrected Snellen visual acuity (VA) of better than 20/200 in the study eye. Patients must see ≥ 50% of the letters on a single line to accept that VA line.
- Central corneal thickness 480-620 μm in the study eye.
- Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.
- Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Screening. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
- All subjects must provide signed written consent prior to participation in any study-related procedures.
Who cannot join
- In the study eye:
- A mean deviation of < -20 dB on VF examination.
- A mean IOP ˃ 28 mm Hg at Baseline.
- Presence of a scotoma within 5° of fixation on VF examination.
- Aphakia.
- Use of any antiglaucoma medication in addition to latanoprost 0.005% ophthalmic solution within 2 weeks prior to Screening and any antiglaucoma medication (other than latanoprost) during the study period other than the randomized study medication.
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- Use of any topical ophthalmic steroid within 2 weeks prior to Baseline. A short course of oral steroids is acceptable if the course is completed > 2 weeks prior to Screening. Inhaled and intranasal steroids are acceptable.
- Use of topical nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Baseline.
- Use of any ophthalmic medications during the study period (nonpreserved artificial tears are allowed).
- Ocular surgery or laser treatment of any kind in the study eye within 3 months prior to Baseline.
- History of ocular allergy/inflammation and/or severe blepharitis and/or uveitis. Seasonal allergic conjunctivitis is acceptable (avoid enrollment of subjects who may experience seasonal flare-up during the study period). Mild blepharitis/blepharoconjunctivitis, typically associated with prostaglandin usage, on the lid is acceptable.
- History of ocular trauma or ocular infection within 3 months of Screening.
- History of herpes simplex keratitis.
- Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
- Severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial erosions of the cornea, and/or use of dry eye medication [including artificial tears] with a frequency exceeding 8 instillations per day).
- Contact lens wear during the study period. Contact lens wear in an untreated fellow eye is allowed.
- Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
- Any severe glaucoma defined by cupping (cup-to-disc ratio ≥ 0.8).
- Any non-laser glaucoma surgery.
- Any abnormality preventing accurate assessment (eg, resulting in unreliable applanation tonometry or VF examination).
- General:
- Pregnancy or lactation.
- Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline-directed therapy).
- Allergy to benzalkonium chloride.
- History of moderate or severe renal or hepatic impairment.
- Participation in any study of an investigational product within 30 days prior to Screening or at any time during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Parallel-Group, Observer-Masked, Phase 3 Study to Compare the Safety and Efficacy of T-2345 Ophthalmic Solution to Xalatan (Latanoprost 0.005%) in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84 days in patients with elevated eye pressure.
Read the detailed description
The objective of this Phase 3 study is to evaluate the efficacy and safety of T-2345 nonpreserved ophthalmic solution (latanoprost 0.005%) in comparison to Xalatan® (latanoprost 0.005%) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH).
This will be a randomized, multicenter, parallel-group, observer-masked study in approximately 380 evaluable subjects treated for 84 days. Subjects will have a history of POAG or OH and elevated intraocular pressure (IOP) and will have been adequately controlled (IOP ≤ 18 mm Hg) on latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks.
Primary efficacy (IOP) will be assessed in the study eye at each visit by Goldmann applanation tonometry at all assessment visits.
Safety will be assessed at each visit by corrected Snellen Visual Acuity, slit lamp examination/anterior chamber cell count and flare and adverse event (AE) collection.
Primary Efficacy Endpoint is the between-group comparison of the mean IOP values at each time point at each of the Day 15, 42, and 84 visits.
Secondary Efficacy Endpoints include:
- Between-group comparison of the mean change from baseline in diurnal IOP measurements at all postbaseline visits.
- Between-group comparison of the mean change from baseline in IOP measurements at all times points at Day 15, Day 42 and Day 84.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- T-2345, Xalatan
- Keywords
- Primary open angle glaucoma, Ocular hypertension
- 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.
T-2345Drug
T-2345 Ophthalmic Solution
XalatanDrug
Xalatan (latanoprost 0.005% ophthalmic solution)
| Study group | Role | What they receive |
|---|---|---|
| T-2345 | Experimental | T-2345 Ophthalmic Solution dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes) Receives: Drug: T-2345 |
| Xalatan | Experimental | Xalatan (Latanoprost 0.005% Ophthalmic Solution) dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes) Receives: Drug: Xalatan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Evaluation of intraocular pressure using Goldmann applanation tonometry.
Primary outcome was the between group difference in the change from baseline in IOP at each of 9 assessment points.
Equivalence was achieved if the 95% Confidence Intervals were within 1.5 mmHg at all 9 time points
Measured: Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84
Secondary outcomes (4)
Visual Acuity
Visual Acuity was measured using the Corrected Snellen Visual Acuity method reported as the Logarithm Minimum Angle of Resoution (logMAR) change from baseline. The Snellen eye chart was used with the subject's current corrected lens prescription at a distance equivalent to 20 feet. Results from the Snellen chart were converted to the logMAR scale which is the standard tool for reporting visual acuity outcomes.
Measured: Baseline and 84 days
Slit Lamp Examination
Number of participants with eye abnormalities following routine slit lamp examination. The anterior segment of the eye including lids, cornea, conjunctiva, anterior chamber, iris and lens were evaluated with a routine slit lamp examination and any abnormalities observed were reported.
Measured: Baseline and 84 days
Ophthalmoscopy
Number of participants with eye abnormalities following ophthalmoscopy. Direct ophthalmoscopy with dilation included assessment of the optic nerve head for pallor and cupping. A dilated fundus examination consisting of the vitreous, optic nerve, macula, and peripheral retina was conducted. Results are reported as the number of subjects with clinical significant abnormalities at Day 84 that were not clinically significant at Baseline.
Measured: Baseline and 84 days
Mean Deviation in Visual Field
Visual Field was performed using an automated perimeter according to the sites standard protocol. This test measures the angle of the visual field from the central visual axis. Visual Field Testing generates a numerical scale as its main result which shows the retinal sensitivities at the different test locations, expressed in Decibels (dB). The mean deviation in the visual field reflects the overall depression (deviation from normal values). Negative values indicate a reduction in visual field. The analysis performed is the mean change from baseline at Day 84.
Measured: Baseline and 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
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 Primary 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
- Outcomes assessor
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nephron Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059278
- Sponsor's protocol ID
- T-2345-001
- Status last verified
- Dec 2017
- First submitted
- 7 Feb 2014
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Parallel-Group, Observer-Masked, Phase 3 Study to Compare the Safety and Efficacy of T-2345 Ophthalmic Solution to Xalatan (Latanoprost 0.005%) in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02059278
- Acronym / sponsor ID
- T-2345-001
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Primary open angle glaucoma, Ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Nephron Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 22 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84 days in patients with elevated eye pressure.
Detailed description
The objective of this Phase 3 study is to evaluate the efficacy and safety of T-2345 nonpreserved ophthalmic solution (latanoprost 0.005%) in comparison to Xalatan® (latanoprost 0.005%) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH).
This will be a randomized, multicenter, parallel-group, observer-masked study in approximately 380 evaluable subjects treated for 84 days. Subjects will have a history of POAG or OH and elevated intraocular pressure (IOP) and will have been adequately controlled (IOP ≤ 18 mm Hg) on latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks.
Primary efficacy (IOP) will be assessed in the study eye at each visit by Goldmann applanation tonometry at all assessment visits.
Safety will be assessed at each visit by corrected Snellen Visual Acuity, slit lamp examination/anterior chamber cell count and flare and adverse event (AE) collection.
Primary Efficacy Endpoint is the between-group comparison of the mean IOP values at each time point at each of the Day 15, 42, and 84 visits.
Secondary Efficacy Endpoints include:
- Between-group comparison of the mean change from baseline in diurnal IOP measurements at all postbaseline visits.
- Between-group comparison of the mean change from baseline in IOP measurements at all times points at Day 15, Day 42 and Day 84.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-2345 | Experimental | Drug: T-2345T-2345 Ophthalmic Solution dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes) |
| Xalatan | Experimental | Drug: XalatanXalatan (Latanoprost 0.005% Ophthalmic Solution) dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 years or older.
- POAG or OH with IOP treated and adequately controlled (IOP ≤ 18 mm Hg) with latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks prior to Screening.
- Each eye being treated with latanoprost 0.005% ophthalmic solution monotherapy must have mean IOP ≤ 18 mm Hg at Screening and mean IOP ≤ 28 mm Hg at Baseline; measurements will be taken at each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes) with AM measurements of IOP at least 2 hours apart. If only one eye qualifies but both eyes have glaucoma and the fellow eye will require antiglaucoma medications, the subject does not qualify for the trial.
- Stable visual field (VF), defined as no sign of VF degradation between two consecutive 30-2 or two consecutive 24-2 VF examinations. For subjects with no VF defect (eg, those with OH), a single, normal VF examination performed ˂ 6 months prior to the screening visit is allowed to determine eligibility. For patients who have an abnormal VF examination, the following criteria apply:
- Stable corrected Snellen visual acuity (VA) of better than 20/200 in the study eye. Patients must see ≥ 50% of the letters on a single line to accept that VA line.
Key exclusion criteria (26 listed)
- A mean deviation of < -20 dB on VF examination.
- A mean IOP ˃ 28 mm Hg at Baseline.
- Presence of a scotoma within 5° of fixation on VF examination.
- Aphakia.
- Use of any antiglaucoma medication in addition to latanoprost 0.005% ophthalmic solution within 2 weeks prior to Screening and any antiglaucoma medication (other than latanoprost) during the study period other than the randomized study medication.
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 |
|---|---|---|
| T-2345T-2345 Ophthalmic Solution | Drug | T-2345 |
| XalatanXalatan (latanoprost 0.005% ophthalmic solution) | Drug | Xalatan |
Primary outcome
Intraocular Pressure
Time frame: Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84
Evaluation of intraocular pressure using Goldmann applanation tonometry. Primary outcome was the between group difference in the change from baseline in IOP at each of 9 assessment points. Equivalence was achieved if the 95% Confidence Intervals were within 1.5 mmHg at all 9 time points
4 secondary outcomes
Visual Acuity
Time frame: Baseline and 84 days
Slit Lamp Examination
Time frame: Baseline and 84 days
Ophthalmoscopy
Time frame: Baseline and 84 days
Mean Deviation in Visual Field
Time frame: Baseline and 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T-2345 and Xalatan in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Nephron Pharmaceuticals Corporation at 1 site 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 12 inclusion and 26 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 22 Aug 2018). 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?
Intraocular Pressure (time frame: Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84). 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 22 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.