Glaucoma, Open-AnglePhase 3NCT05401357
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
A Phase 3 study testing Test - Bimatoprost 0.01% Ophthalmic Solution and Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Amneal Pharmaceuticals, LLC at 9 sites in United States.
Trial summary
This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Test - Bimatoprost 0.01% Ophthalmic Solution and Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 9 sitesUnited States
- Study dates
- 29 Jun 2022to Dec 2022
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 having body mass index (BMI) ≥18.50 kg/m2.
- 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 per the table below (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.
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- Baseline (Day 0/hour 0) IOP ≥22 mm Hg and <35 mm Hg in each eye,
- 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.
- Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
- Current or past 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.
- Functionally significant visual field loss in the Investigators' opinion.
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- 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 90 days before the first dose of the study drug
- Subjects with documented 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
- Subjects with confirmed novel coronavirus infection (COVID-19).
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Not yet recruiting
Keystone Research
Austin, Texas, 78731
Robert Marquis, MD
Trisha Locke, 512-777-0979, tlocke@keystoneresearch.com
- Recruiting
Cheyenne Eye Clinic & Surgery Center
Cheyenne, Wyoming, 82001
Anne Miller, MD
Courtney Moon, 970-419-2696, cmoon@panoramaeyecare.com
- Recruiting
Houston Eye Associates, North Loop
Houston, Texas, 77008
Kevin Jong, MD
Bhavana Shah, 832-553-7113, bshah@houstoneye.com
- Recruiting
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Jennifer Kim, MD
Helen Dubiner, 404-520-1111, helendubiner@hotmail.com
- Recruiting
Toyos Clinic
Nashville, Tennessee, 37215
Melissa Toyos, MD
Alison Moore, MD, 901-651-8431, alisonmoore@sco.edu
- Recruiting
Volusia Eye Associates
New Smyrna Beach, Florida, 32169
Hank Routh, MD
Shatonia Fields, 386-785-2400, sfields@accelclinical.com
- Recruiting
Eye Research Foundation Inc.
Newport Beach, California, 92663
David Wirta, MD, 949-554-8763
- Recruiting
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Jason Bacharach, MD
Eduardo Chavez, 707-769-2237, echavez@northbayeye.com
- Recruiting
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Douglas Day, MD
John Schuhr, 404-895-9257, john@coastalresearchassociates.com
About this study
Official title: A Randomized, Double-blind, Multiple Dose, Parallel-group, Two-arm, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing 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
This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
Read the detailed description
Subjects with chronic open-angle glaucoma or ocular hypertension in both the eyes and meeting all the mentioned inclusion criteria and none of the exclusion criteria will be identified. At baseline (Day 0), subjects qualifying Intra Ocular Pressure (IOPs) following wash-out, with difference between the IOP in left and right eyes not being more than 5 mm Hg, will be randomized.
Subjects will instill 1 drop of study drug (either T or R) in both eyes every evening at approximately 10:00 pm for 42 days.
The study subjects will undergo clinical evaluations throughout the study in order to assess safety and efficacy. Primary endpoint evaluation will be assessed after 2 weeks (Day 14) and 6 weeks (Day 42) of treatment for each study subject deemed eligible for evaluation.
The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Test - Bimatoprost 0.01% Ophthalmic Solution, Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
- Keywords
- Bimatoprost ophthalmic solution 0.01% in both eyes, Chronic open-angle glaucoma in both eyes
- 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.
Test - Bimatoprost 0.01% Ophthalmic SolutionDrug
Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days.
Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)Drug
Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | Experimental | Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc. Receives: Drug: Test - Bimatoprost 0.01% Ophthalmic Solution |
| LUMIGAN® 0.01% Ophthalmic Solution | Active comparator | Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc. Receives: Drug: Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.
Change in mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hour, 04.00 hours, and 08.00 hours at Day 14 (Week 2) and Day 42 (Week 6) visits
Measured: Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Secondary outcomes (1)
AE Monitoring for Safety of Bimatoprost ophthalmic solution 0.01%
Safety will be evaluated throughout the study based on adverse event monitoring,
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 posted2 Jun 2022
- Study start29 Jun 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Model description
- Participants are randomly assigned to either group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401357
- Sponsor's protocol ID
- CBCC/2021/025
- Status last verified
- Aug 2022
- First submitted
- 27 Apr 2022
- Last updated
- 10 Aug 2022
- 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 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multiple Dose, Parallel-group, Two-arm, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing 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
- NCT05401357
- Acronym / sponsor ID
- CBCC/2021/025
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Bimatoprost ophthalmic solution 0.01% in both eyes, Chronic open-angle glaucoma in both eyes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Jun 2022 (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.
This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
Detailed description
Subjects with chronic open-angle glaucoma or ocular hypertension in both the eyes and meeting all the mentioned inclusion criteria and none of the exclusion criteria will be identified. At baseline (Day 0), subjects qualifying Intra Ocular Pressure (IOPs) following wash-out, with difference between the IOP in left and right eyes not being more than 5 mm Hg, will be randomized.
Subjects will instill 1 drop of study drug (either T or R) in both eyes every evening at approximately 10:00 pm for 42 days.
The study subjects will undergo clinical evaluations throughout the study in order to assess safety and efficacy. Primary endpoint evaluation will be assessed after 2 weeks (Day 14) and 6 weeks (Day 42) of treatment for each study subject deemed eligible for evaluation.
The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either group
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | Experimental | Drug: Test - Bimatoprost 0.01% Ophthalmic SolutionPharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc. |
| LUMIGAN® 0.01% Ophthalmic Solution | Active comparator | Drug: Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females aged ≥18 years.
- Subjects having body mass index (BMI) ≥18.50 kg/m2.
- 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.
Key exclusion criteria (28 listed)
- Female who are pregnant, lactating or planning a pregnancy.
- Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
- Current or past 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.
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 |
|---|---|---|
| Test - Bimatoprost 0.01% Ophthalmic SolutionSubjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days. | Drug | Bimatoprost 0.01% Ophthalmic Solution |
| Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days. | Drug | LUMIGAN® 0.01% Ophthalmic Solution |
Primary outcome
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.
Time frame: Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Change in mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hour, 04.00 hours, and 08.00 hours at Day 14 (Week 2) and Day 42 (Week 6) visits
1 secondary outcome
AE Monitoring for Safety of Bimatoprost ophthalmic solution 0.01%
Time frame: AE Monitoring for Safety will be evaluated throughout the study for 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- 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.
9 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 Test - Bimatoprost 0.01% Ophthalmic Solution and Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Amneal Pharmaceuticals, LLC at 9 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 17 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: looking for participants now, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilesh Changela, MBBS; MD (+91-79-67778300 ext. 9011, ilesh@amnealindia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups. (time frame: Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.). 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 10 Aug 2022.