Open-Angle GlaucomaPhase 2NCT04910100
Nebivolol 0.5, 1.0, or Timolol 0.5 Suspension Compared to Timolol 0.5 Solution to Treat Glaucoma/Ocular Hypertension
A Phase 2 study testing Nebivolol Ophthalmic Suspension 1 Percent, Nebivolol Ophthalmic Suspension 0.5 Percent and Timolol Ophthalmic Suspension 0.5 Percent in people with Open-Angle Glaucoma and Ocular Hypertension, run by Betaliq, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety (in the eye and throughout the body) and effectiveness of nebivolol (0.5 and 1 percent) and timolol (0.5 percent) eye drop suspensions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Nebivolol Ophthalmic Suspension 1 Percent, Nebivolol Ophthalmic Suspension 0.5 Percent and Timolol Ophthalmic Suspension 0.5 Percent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 29 Apr 2022
- Phase
- Phase 2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to understand and sign an informed consent form prior to any study related procedures.
- Able to administer or have a caregiver accurately administer an eye drop.
- Have POAG or OHT in both eyes that requires therapy for IOP and is adequately controlled, in the opinion of the Investigator, on no more than 2 ocular hypotensive medications (fixed dose combinations count as 2 medications). Subjects with OHT on no ocular hypotensive medication are acceptable. Presence of POAG in one eye and OHT in the fellow eye is acceptable.
- 3. Able, in the opinion of the Investigator, to safely discontinue use of ocular hypotensive medications, if applicable, and undergo the appropriate required washout period for ocular hypotensive medications prior to Visit 3/Qualification/Baseline.
- 4. At Visit 3/Qualification/Baseline, at least one eye must have unmedicated (post washout) IOP ≥ 22 and ≤ 34 mm Hg at 8:00 AM and ≥ 18 and ≤ 34 mm Hg at 10:00 AM and 4:00 PM in the same eye(s) qualifying at the Visit 3 8:00 AM time point. The IOP must be at least 22 mm Hg at each consecutive measurement at the 8:00 AM time point.
- 5. No significant VF (visual field) loss, defined as a mean deviation in either eye greater than - 12 dB or a central point of fixation < 5 dB in either eye. If the VF performed at or within 90 days prior to Visit 1 does not meet study required parameters, it may be repeated (test should be prior to randomization at Visit 3/Qualification/Baseline).
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- 6. Best corrected visual acuity (BCVA) of +0.6 logMAR or better in both eyes at Visit 1/Screening and Visit 3/Qualification/Baseline.
- 7. Central corneal thickness ≥ 480 and ≤ 600 μm in both eyes. Pachymetry within 90 days prior to Screening is acceptable.
- 8. Shaffer gonioscopic grade ≥ 3 (in at least 3 quadrants) in both eyes. Gonioscopy within 90 days prior to randomization is acceptable.
- 9. Female subjects must be 1-year postmenopausal, surgically sterilized (total hysterectomy, bilateral oophorectomy or bilateral tubal ligation > 90 days prior to Visit 1/Screening), or women of childbearing potential with a negative urine pregnancy test at Visit 1/Screening and Visit 3/Qualification/Baseline who are not breastfeeding or planning a pregnancy during the study. 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 (IUD) device
- Hormonal contraceptive (oral, injection, patch, implant, ring); subjects must have been on the same hormonal contraceptive for ≥ 90 days prior to Visit 1/Screening
- Double barrier method (spermicide used with either a condom or diaphragm)
- Abstinence
Who cannot join
- Ocular
- Intraocular pressure ˃ 34 mm Hg in either eye at Visit 1/Screening, Visit 2/Washout Safety Check, or Visit 3/Qualification/Baseline.
- Other forms of glaucoma in either eye, e.g., congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, pseudoexfoliation or pigment dispersion syndrome, or history of angle closure. Narrow angles treated with peripheral iridotomy are allowed if at least 4 months status post iridotomy.
- Current or recent (within 30 days prior to Visit 1/Screening) clinically significant ocular infection or inflammation, in the opinion of the Investigator, in either eye.
- History of conjunctivitis within 90 days prior to Visit 1/Screening, or history of herpes simplex or herpes zoster in either eye.
- Clinically significant ocular disease, in the opinion of the Investigator, in either eye (including, but not limited to corneal edema, uveitis, severe dry eye, proliferative diabetic retinopathy or macular degeneration) that might interfere with the study, confound study results, or put the subject at increased risk.
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- Have a cup-to disc (CD) ratio > 0.8 at Visit 1/Screening in either eye.
- Intravitreal steroid injections within 6 months prior to Visit 1/Screening. Subconjunctival or subtenon steroid injections within 90 days prior to Visit 1/Screening.
- Use of topical ocular medications within 30 days prior to Visit 1/Screening other than ocular hypotensive medications and medications used as part of an eye examination. Artificial tears may be used during this period provided the use is not required for severe dry eye disease.
- Clinically significant ocular trauma or incisional ocular surgery (including routine cataract surgery) in either eye within 6 months prior to Visit 1/Screening. Glaucoma filtering surgery, or minimally invasive glaucoma surgery within 12 months prior to Visit 1/Screening. Laser surgery for IOP reduction within 6 months prior to Visit 1/Screening. Non-incisional ocular surgery or non-glaucomatous laser treatment within 90 days prior to Visit 1/Screening.
- Refractive surgery in either eye (i.e., radial keratotomy, photorefractive keratectomy [PRK], laser-assisted in situ keratomileusis [LASIK], corneal cross-linking, limbal relaxing incision) within 6 months prior to Visit 1/Screening.
- Any ocular (e.g., corneal) abnormality preventing accurate assessment of IOP.
- Contact lens wear within 1 week prior to Visit 1/Screening or unwillingness to discontinue wear of contacts lenses prior to and during the study period.
- Aphakia.
- General
- Pregnancy or lactation.
- Known hypersensitivity or contraindication to β-blockers (i.e., chronic obstructive pulmonary disease, bronchial asthma, unstable or abnormally low blood pressure or heart rate, second or third degree heart block or congestive heart failure, severe or unstable diabetes mellitus) that in the opinion of the Investigator may put the subject at risk from a topical ocular beta-blocker.
- Have a condition or be in a situation which, in the Investigator's opinion, may put the subject at significant risk, confound study results, or interfere with the subject's participation in the study.
- Clinically significant systemic disease (myasthenia gravis, hepatic, renal, endocrine, or cardiovascular disorders) that in the opinion of the Investigator might interfere with the study.
- Use of systemic beta-adrenergic antagonists unless the dosage has been stable for 1 month prior to Visit 1/Screening and is expected to remain stable through the study period.
- Use of systemic (oral, injectable, inhaled) or topical steroids within 30 days prior to Visit 1/Screening; topical dermatologic or intranasal steroids are acceptable provided the usage meets the criteria outlined in the Summary of Prohibited Medications and Procedures in the protocol.
- Contraindication to the use of timolol, nebivolol, or any of the components of the investigational products.
- Changes to systemic medication that could have an effect on IOP within 28 days prior to Visit 3/Qualification/Baseline.
- Participation in any study of an investigational product within 30 days prior to Visit 1/Screening.
- History of substance abuse within 1 year prior to Visit 1/Screening.
- Screening and enrollment of employees or relatives of employees of the clinical site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Multicenter, Observer-Masked Study to Compare Safety/Efficacy of Nebivolol Suspension 0.5% or 1.0%, or Timolol Suspension 0.5% to Timolol Solution 0.5% in Participants With Primary Open Angle Glaucoma or Ocular Hypertension
The purpose of this study is to evaluate the safety (in the eye and throughout the body) and effectiveness of nebivolol (0.5 and 1 percent) and timolol (0.5 percent) eye drop suspensions. These eye drops will be compared to timolol 0.5 percent eye drop solution in participants with open angle glaucoma (the most common type of glaucoma) or high eye pressure (ocular hypertension).
Read the detailed description
The study will enroll 240 participants (60 in each treatment arm) who will be treated for 84 days (12 weeks). Participants will have OAG (open angle glaucoma) or OHT (ocular hypertension) in both eyes (OAG in one eye and OHT in the follow eye is acceptable) that requires therapy and elevated IOP (intraocular pressure) adequately controlled on no more than 2 ocular hypertensive medications. Participants with OHT on no ocular hypotensive medications are acceptable. After being informed about the study and potential risks, participants giving written informed consent will undergo an washout period, if required, from previous glaucoma medications (28 days for prostaglandin analogs, rho-associated protein kinase inhibitors, or beta blockers; 14 days for adrenergic agonists; and 5 days for muscarinic agonists or carbonic anhydrase inhibitors). Eligible participants must have unmedicated IOP measurements at Visit 3/Baseline ≥ 22 and ≤ 34 mm Hg at 8:00 AM and ≥ 18 and ≤ 34 mm Hg at 10:00 AM and 4:00 PM (each qualifying eye must fall within the required IOP range at all 3 time points and must be at least 22 mm Hg at each consecutive measurement at the 8:00 AM time point). Both eyes will be treated twice daily. Study visits will comprise Visit 1/Screening/Day -35 to -1, Visit 2/Washout Safety Check/Day -14 ± 3 (performed for participants undergoing 28-day washout periods at the Investigator's discretion), Visit 3/Qualification/Baseline/Day 1, Visit 4/Day 15 ± 3, Visit 5/Day 42 ± 3, and Visit 6/Day 84 ± 3. At Visits 4, 5, and 6, participants will be evaluated at 8:00 AM, at 2 hours after study medication dosing at the clinical site (approximately 10:00 AM), and at 4:00 PM (each ± 30 minutes). All ophthalmic assessments will be performed bilaterally.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- Nebivolol Ophthalmic Suspension 1 Percent, Nebivolol Ophthalmic Suspension 0.5 Percent, Timolol Ophthalmic Suspension 0.5 Percent, Timolol Ophthalmic Solution 0.5 Percent
- 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.
Nebivolol Ophthalmic Suspension 1 PercentDrug
1 drop instilled into each eye twice daily
Nebivolol Ophthalmic Suspension 0.5 PercentDrug
1 drop instilled into each eye twice daily
Timolol Ophthalmic Suspension 0.5 PercentDrug
1 drop instilled into each eye twice daily
Timolol Ophthalmic Solution 0.5 PercentDrug
1 drop instilled into each eye twice daily
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol Ophthalmic Suspension 1 Percent | Experimental | Administered twice daily to both eyes for 84 days (12 weeks) Receives: Drug: Nebivolol Ophthalmic Suspension 1 Percent |
| Nebivolol Ophthalmic Suspension 0.5 Percent | Experimental | Administered twice daily to both eyes for 84 days (12 weeks) Receives: Drug: Nebivolol Ophthalmic Suspension 0.5 Percent |
| Timolol Ophthalmic Suspension 0.5 Percent | Experimental | Administered twice daily to both eyes for 84 days (12 weeks) Receives: Drug: Timolol Ophthalmic Suspension 0.5 Percent |
| Timolol Ophthalmic Solution 0.5 Percent | Active comparator | Administered twice daily to both eyes for 84 days (12 weeks) Receives: Drug: Timolol Ophthalmic Solution 0.5 Percent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure Over 84 Days
Measured utilizing a calibrated Goldmann tonometer; two consecutive IOP measurements of each eye will be performed. If the 2 measurements differ by more than 2 mm Hg, a third measurement will be taken. The primary efficacy analysis will be the between-group comparison of the mean IOP values in the study eye at 10AM, 2 hours postdose, and 4PM, at each of the Visit 4/Day 15, Visit 5/Day 42, and Visit 6/Day 84 visits (ie, a total of 9 between-group comparisons). A hierarchical analysis will be conducted to compare each of the investigational products against the comparator, timolol 0.5% ophthalmic solution, as follows: (1) nebivolol 1% ophthalmic suspension, (2) nebivolol 0.5% ophthalmic suspension, and (3) timolol ophthalmic suspension.
Measured: Over 84 days
Secondary outcomes (2)
Intraocular Pressure: Change From Baseline in Diurnal IOP at Each Visit
Change from baseline (Visit 3/Qualification/Baseline) in the average of the 3 daily IOP measurements at Day 15, Day 42, and Day 84
Measured: Day 15: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 42: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 84: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes
Intraocular Pressure: Change From Baseline at All Time Points at Each Visit
Time-matched change from baseline (Visit 3/Qualification/Baseline) in the 3 daily IOP measurements at Day 15, Day 42 and Day 84
Measured: Day 15: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 42: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 84: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start15 Apr 2021
- Primary completion31 Mar 2022
- Study completion29 Apr 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized in a 1:1:1:1 ratio to 4 treatment arms: nebivolol 0.5% ophthalmic suspension; nebivolol 1.0% ophthalmic suspension; timolol 0.5% ophthalmic suspension; and timolol 0.5% ophthalmic solution.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betaliq, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trial Runners, LLC, Summit Analytical LLC
- Responsible party
- Sponsor
- Investigators
- Kristin Peterson, Study director, Trial Runners, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910100
- Sponsor's protocol ID
- BTQ-1901-1902-201
- Status last verified
- Apr 2024
- First submitted
- 10 May 2021
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Observer-Masked Study to Compare Safety/Efficacy of Nebivolol Suspension 0.5% or 1.0%, or Timolol Suspension 0.5% to Timolol Solution 0.5% in Participants With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT04910100
- Acronym / sponsor ID
- BTQ-1901-1902-201
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Betaliq, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Trial Runners, LLC, Summit Analytical LLC
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety (in the eye and throughout the body) and effectiveness of nebivolol (0.5 and 1 percent) and timolol (0.5 percent) eye drop suspensions. These eye drops will be compared to timolol 0.5 percent eye drop solution in participants with open angle glaucoma (the most common type of glaucoma) or high eye pressure (ocular hypertension).
Detailed description
The study will enroll 240 participants (60 in each treatment arm) who will be treated for 84 days (12 weeks). Participants will have OAG (open angle glaucoma) or OHT (ocular hypertension) in both eyes (OAG in one eye and OHT in the follow eye is acceptable) that requires therapy and elevated IOP (intraocular pressure) adequately controlled on no more than 2 ocular hypertensive medications. Participants with OHT on no ocular hypotensive medications are acceptable. After being informed about the study and potential risks, participants giving written informed consent will undergo an washout period, if required, from previous glaucoma medications (28 days for prostaglandin analogs, rho-associated protein kinase inhibitors, or beta blockers; 14 days for adrenergic agonists; and 5 days for muscarinic agonists or carbonic anhydrase inhibitors). Eligible participants must have unmedicated IOP measurements at Visit 3/Baseline ≥ 22 and ≤ 34 mm Hg at 8:00 AM and ≥ 18 and ≤ 34 mm Hg at 10:00 AM and 4:00 PM (each qualifying eye must fall within the required IOP range at all 3 time points and must be at least 22 mm Hg at each consecutive measurement at the 8:00 AM time point). Both eyes will be treated twice daily. Study visits will comprise Visit 1/Screening/Day -35 to -1, Visit 2/Washout Safety Check/Day -14 ± 3 (performed for participants undergoing 28-day washout periods at the Investigator's discretion), Visit 3/Qualification/Baseline/Day 1, Visit 4/Day 15 ± 3, Visit 5/Day 42 ± 3, and Visit 6/Day 84 ± 3. At Visits 4, 5, and 6, participants will be evaluated at 8:00 AM, at 2 hours after study medication dosing at the clinical site (approximately 10:00 AM), and at 4:00 PM (each ± 30 minutes). All ophthalmic assessments will be performed bilaterally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Eligible participants will be randomized in a 1:1:1:1 ratio to 4 treatment arms: nebivolol 0.5% ophthalmic suspension; nebivolol 1.0% ophthalmic suspension; timolol 0.5% ophthalmic suspension; and timolol 0.5% ophthalmic solution.
| Arm | Type | Receives |
|---|---|---|
| Nebivolol Ophthalmic Suspension 1 Percent | Experimental | Drug: Nebivolol Ophthalmic Suspension 1 PercentAdministered twice daily to both eyes for 84 days (12 weeks) |
| Nebivolol Ophthalmic Suspension 0.5 Percent | Experimental | Drug: Nebivolol Ophthalmic Suspension 0.5 PercentAdministered twice daily to both eyes for 84 days (12 weeks) |
| Timolol Ophthalmic Suspension 0.5 Percent | Experimental | Drug: Timolol Ophthalmic Suspension 0.5 PercentAdministered twice daily to both eyes for 84 days (12 weeks) |
| Timolol Ophthalmic Solution 0.5 Percent | Active comparator | Drug: Timolol Ophthalmic Solution 0.5 PercentAdministered twice daily to both eyes for 84 days (12 weeks) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to understand and sign an informed consent form prior to any study related procedures.
- Able to administer or have a caregiver accurately administer an eye drop.
- Have POAG or OHT in both eyes that requires therapy for IOP and is adequately controlled, in the opinion of the Investigator, on no more than 2 ocular hypotensive medications (fixed dose combinations count as 2 medications). Subjects with OHT on no ocular hypotensive medication are acceptable. Presence of POAG in one eye and OHT in the fellow eye is acceptable.
- 3. Able, in the opinion of the Investigator, to safely discontinue use of ocular hypotensive medications, if applicable, and undergo the appropriate required washout period for ocular hypotensive medications prior to Visit 3/Qualification/Baseline.
- 4. At Visit 3/Qualification/Baseline, at least one eye must have unmedicated (post washout) IOP ≥ 22 and ≤ 34 mm Hg at 8:00 AM and ≥ 18 and ≤ 34 mm Hg at 10:00 AM and 4:00 PM in the same eye(s) qualifying at the Visit 3 8:00 AM time point. The IOP must be at least 22 mm Hg at each consecutive measurement at the 8:00 AM time point.
Key exclusion criteria (26 listed)
- Ocular
- Intraocular pressure ˃ 34 mm Hg in either eye at Visit 1/Screening, Visit 2/Washout Safety Check, or Visit 3/Qualification/Baseline.
- Other forms of glaucoma in either eye, e.g., congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, pseudoexfoliation or pigment dispersion syndrome, or history of angle closure. Narrow angles treated with peripheral iridotomy are allowed if at least 4 months status post iridotomy.
- Current or recent (within 30 days prior to Visit 1/Screening) clinically significant ocular infection or inflammation, in the opinion of the Investigator, in either eye.
- History of conjunctivitis within 90 days prior to Visit 1/Screening, or history of herpes simplex or herpes zoster in either eye.
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 |
|---|---|---|
| Nebivolol Ophthalmic Suspension 1 Percent1 drop instilled into each eye twice daily | Drug | Nebivolol Ophthalmic Suspension 1 Percent |
| Nebivolol Ophthalmic Suspension 0.5 Percent1 drop instilled into each eye twice daily | Drug | Nebivolol Ophthalmic Suspension 0.5 Percent |
| Timolol Ophthalmic Suspension 0.5 Percent1 drop instilled into each eye twice daily | Drug | Timolol Ophthalmic Suspension 0.5 Percent |
| Timolol Ophthalmic Solution 0.5 Percent1 drop instilled into each eye twice daily | Drug | Timolol Ophthalmic Solution 0.5 Percent |
Primary outcome
Intraocular Pressure Over 84 Days
Time frame: Over 84 days
Measured utilizing a calibrated Goldmann tonometer; two consecutive IOP measurements of each eye will be performed. If the 2 measurements differ by more than 2 mm Hg, a third measurement will be taken. The primary efficacy analysis will be the between-group comparison of the mean IOP values in the study eye at 10AM, 2 hours postdose, and 4PM, at each of the Visit 4/Day 15, Visit 5/Day 42, and Visit 6/Day 84 visits (ie, a total of 9 between-group comparisons). A hierarchical analysis will be conducted to compare each of the investigational products against the comparator, timolol 0.5% ophthalmic solution, as follows: (1) nebivolol 1% ophthalmic suspension, (2) nebivolol 0.5% ophthalmic suspension, and (3) timolol ophthalmic suspension.
2 secondary outcomes
Intraocular Pressure: Change From Baseline in Diurnal IOP at Each Visit
Time frame: Day 15: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 42: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 84: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes
Intraocular Pressure: Change From Baseline at All Time Points at Each Visit
Time frame: Day 15: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 42: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 84: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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.
Kristin Peterson study director
Trial Runners, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nebivolol Ophthalmic Suspension 1 Percent, Nebivolol Ophthalmic Suspension 0.5 Percent and Timolol Ophthalmic Suspension 0.5 Percent in people with Open-Angle Glaucoma and Ocular Hypertension, run by Betaliq, Inc. 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 14 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 17 Apr 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Apr 2024). 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 Over 84 Days (time frame: Over 84 days). 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 17 Apr 2024.