Open-angle GlaucomaPhase 1NCT06267274
A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
A Phase 1 study testing Bimatoprost Ophthalmic Solution, 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in people with Open-angle Glaucoma and Ocular Hypertension, run by Amneal Pharmaceuticals, LLC at 4 sites in United States.
Trial summary
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- Bimatoprost Ophthalmic Solution, 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Apr 2024to 1 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females aged ≥18 years.
- Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
- Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
- Adequate washout period prior to baseline of any ocular hypotensive medications as (to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all the subjects must have discontinued their ocular hypotensive medications for the minimum washout period .
- Baseline (Day 0/hour 0) IOP ≥22 mm Hg and <28 mm Hg in each eye, with difference between the IOP in left and right eyes not being more than 5 mm Hg
Show all 16Show fewer
- Subjects' IOP is likely to be controlled with monotherapy as per the Investigator's discretion.
- Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).
- Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the dosing of the study drug) practicing any of the following acceptable methods of contraception:
- Oral or parenteral (injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication.
- Intrauterine device (IUD) or intrauterine system (IUS)
- Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
- Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject)
- Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
- Total abstinence; partial abstinence is not acceptable
- No history of addiction to any recreational drug or drug dependence or alcohol addiction
Who cannot join
- Female who are pregnant, lactating or planning a pregnancy.
- Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and who are treatment naive.
- Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
- Current or history of severe hepatic or renal impairment.
- Current or history within 2 months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met).
- Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer.
Show all 28Show fewer
- Functionally significant visual field loss in the Investigators' opinion.
- Subject with corneal grafts.
- Subject has contraindication to pupil dilation.
- Use at any time prior to baseline of an intraocular corticosteroid implant.
- Use of contact lens within 1 week prior to baseline.
- Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid.
- Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high-dose salicylate therapy defined as 325 mg/day and taken on 3 consecutive days.
- Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid.
- Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery).
- Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).
- Amblyopia - only one sighted eye.
- Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy.
- Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination.
- Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup/disk ratio greater than 0.8 (not including physiological cupping in the Investigators' opinion) or split fixation.
- Chronic use of any systemic medication that may affect IOP with less than 3 months stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
- Central Corneal thickness (CCT) <450 microns or >650 microns.
- Known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
- History of recurrent ocular seasonal allergies within the past 2 years.
- Any other medical condition or serious intercurrent illness that, in the Investigator's opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements.
- Participation in any clinical study within 30 days before the first dose of the study drug.
- Subjects with known history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection.
- Subjects with positive urine pregnancy test.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
West Coast Eye Institute
Bakersfield, California, 93308
Sandeep Walia, MD
- Recruiting
Houston Eye Associates
Houston, Texas, 77008
Kevin Jong, MD
- Recruiting
Clayton Eye Research
Morrow, Georgia, 30260
Kim Jong, MD
- Recruiting
Eye Research Foundation
Newport Beach, California, 92663
David Wirta, MD
About this study
Official title: A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Generic Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study
Read the detailed description
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes who meet all of the inclusion criteria and none of the exclusion criteria will be identified.
Potential subjects will be screened within 6 weeks prior to administration of the first drop of study drug. They will undergo a washout period of 4 days to 4 weeks (28 days) based on their current medication (if available). Based on stratification criteria, IOP and CCT information available at baseline visit for each subject, the subjects will be randomized in such way that ratio of treatment distribution will be nearer to 1:1 between the treatment arms, and within the combined stratification criteria. The Primary Endpoint is mean difference in the IOP of both eyes between the two treatment groups at 3 time points, i.e., at 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits.
The Secondary Endpoint: the incidence of all adverse events reported during the study will be summarized by treatment group. Test and reference products will be compared for safety by analyzing nature, severity and frequency of treatment emergent adverse events.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Bimatoprost Ophthalmic Solution, 0.01%, LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
- 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.
Bimatoprost Ophthalmic Solution, 0.01%Drug
1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.
LUMIGAN® (bimatoprost ophthalmic solution) 0.01%Drug
1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost Ophthalmic Solution, 0.01% | Experimental | Test Product: Bimatoprost Ophthalmic Solution, 0.01% Receives: Drug: Bimatoprost Ophthalmic Solution, 0.01% |
| LUMIGAN® (bimatoprost ophthalmic solution) 0.01% | Active comparator | Reference Product: LUMIGAN® (bimatoprost ophthalmic solution) 0.01% Receives: Drug: LUMIGAN® (bimatoprost ophthalmic solution) 0.01% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Mean difference in the IOP of both eyes between the two treatment groups at 3 time points
Measured: 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits
Secondary outcomes (1)
Secondary Endpoint
The incidence of all adverse events reported during the study will be summarized by treatment group. Test and reference products will be compared for safety by analyzing nature, severity and frequency of treatment emergent adverse events.
Measured: AE Monitoring for Safety will be evaluated throughout the study for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Apr 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in such way that ratio of treatment distribution will be nearer to 1:1 between the treatment arms, and within the combined stratification criteria.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Inc., Amneal EU, Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267274
- Sponsor's protocol ID
- MW230021
- Status last verified
- Aug 2024
- First submitted
- 12 Feb 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Generic Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
- ClinicalTrials.gov ID
- NCT06267274
- Acronym / sponsor ID
- MW230021
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Inc., Amneal EU, Limited
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study
Detailed description
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes who meet all of the inclusion criteria and none of the exclusion criteria will be identified.
Potential subjects will be screened within 6 weeks prior to administration of the first drop of study drug. They will undergo a washout period of 4 days to 4 weeks (28 days) based on their current medication (if available). Based on stratification criteria, IOP and CCT information available at baseline visit for each subject, the subjects will be randomized in such way that ratio of treatment distribution will be nearer to 1:1 between the treatment arms, and within the combined stratification criteria. The Primary Endpoint is mean difference in the IOP of both eyes between the two treatment groups at 3 time points, i.e., at 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits.
The Secondary Endpoint: the incidence of all adverse events reported during the study will be summarized by treatment group. Test and reference products will be compared for safety by analyzing nature, severity and frequency of treatment emergent adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in such way that ratio of treatment distribution will be nearer to 1:1 between the treatment arms, and within the combined stratification criteria.
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost Ophthalmic Solution, 0.01% | Experimental | Drug: Bimatoprost Ophthalmic Solution, 0.01%Test Product: Bimatoprost Ophthalmic Solution, 0.01% |
| LUMIGAN® (bimatoprost ophthalmic solution) 0.01% | Active comparator | Drug: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%Reference Product: LUMIGAN® (bimatoprost ophthalmic solution) 0.01% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females aged ≥18 years.
- Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
- Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
- Adequate washout period prior to baseline of any ocular hypotensive medications as (to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all the subjects must have discontinued their ocular hypotensive medications for the minimum washout period .
Key exclusion criteria (28 listed)
- Female who are pregnant, lactating or planning a pregnancy.
- Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and who are treatment naive.
- Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
- Current or history of severe hepatic or renal impairment.
- Current or history within 2 months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met).
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 |
|---|---|---|
| Bimatoprost Ophthalmic Solution, 0.01%1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule. | Drug | Bimatoprost Ophthalmic Solution, 0.01% |
| LUMIGAN® (bimatoprost ophthalmic solution) 0.01%1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule. | Drug | LUMIGAN® (bimatoprost ophthalmic solution) 0.01% |
Primary outcome
Primary Endpoint
Time frame: 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits
Mean difference in the IOP of both eyes between the two treatment groups at 3 time points
1 secondary outcome
Secondary Endpoint
Time frame: AE Monitoring for Safety will be evaluated throughout the study for 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Open-angle Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bimatoprost Ophthalmic Solution, 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in people with Open-angle Glaucoma and Ocular Hypertension, run by Amneal Pharmaceuticals, LLC at 4 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 16 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilesh Changela, MD (+91-79-67778300 ext. 9011, ilesh@amneal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits). 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 6 Aug 2024.