Glaucoma, Open-AnglePhase 3GlaucomaNCT04890106
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% to LUMIGAN® In The Treatment of Chronic Open-Angle Glaucoma
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, run by Mankind Pharma Limited at 9 sites in United States.
Trial summary
This is a randomized, double-masked, 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
- 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
- 310 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Oct 2021to 11 Aug 2022
- Phase
- Phase 3
- 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 the protocol requirements
- Male or non-pregnant females aged ≥18 years having body mass index (BMI) ≥ 17 calculated as weight in kg/height in m2.
- Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
- Subjects requiring treatment of both the eyes and can discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo an appropriate washout period
- Adequate wash-out period prior to baseline of any ocular hypotensive medication as per the table below (In order 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 subjects must have discontinued all ocular hypotensive medications for the minimum washout period
- Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and difference in IOP between the eyes is not greater than 5 mm Hg
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- Subject's IOP is likely to be controlled with monotherapy as per the discretion of the investigator
- Baseline best-corrected visual acuity equivalent to 20/200 (6/60) or better in each eye
- Women of child-bearing potential (defined as women physiologically capable of becoming pregnant, unless they are using an effective contraception method during dosing of the investigational product) practicing any two acceptable contraception methods
- Acceptable methods of contraception are:
- Oral or parenteral (injection) , patch, or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
- Intrauterine device (IUD) or intrauterine system IUS)
- A double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
- Male sterilization (at least six months prior to the screening, should be the sole male partner for that subject)
- Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least six 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
- Hypersensitivity to Bimatoprost or related class of drugs or any of the excipients of the formulation
- Severe hepatic or renal impairment
- Current or history within two months prior to the 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 investigator's discretion) will be allowed provided other inclusion/exclusion criteria are met
- Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer
- Functionally significant visual field loss
- Use of an intraocular corticosteroid implant at any time prior to the baseline
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- Use of contact lens within one week prior to the baseline
- Use of 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid within two weeks prior to the baseline
- Use of 1) systemic corticosteroid or 2) high-dose salicylate therapy defined as 325mg/day taken on three consecutive days, within one month prior to the baseline
- Use of intravitreal or subtenon injection of ophthalmic corticosteroid within six months prior to the baseline
- Underwent any other intraocular surgery (e.g., cataract surgery) within six months prior to the baseline
- Underwent refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty) within twelve months prior to the baseline
- Amblyopia/only one sighted eye
- Subjects with a past history of IOP previously uncontrolled on bimatoprost monotherapy
- Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup/disk ratio greater than 0.8, split fixation, or functionally significant (in the investigators' opinion) visual field loss
- Chronic use of any systemic medication that may affect IOP with less than a three-month 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.)
- 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 two years
- Any other medical condition or severe intercurrent illness that, in the investigator's opinion, may make it undesirable for the subjects to participate in the study and would limit adherence to the study's requirements
- Pregnant or lactating woman
- Subjects with suspected signs and symptoms of COVID-19/confirmed novel coronavirus infection (COVID-19) or with a recent history (within 14 days) of travel/contact with any COVID-19 positive subject/isolation/quarantine
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
CBCC Global Research Site:011
Bakersfield, California, 93308
CBCC Global Research Site 018
Houston, Texas, 77008
CBCC Global Research Site 016
Mission Hills, California, 91345
CBCC Global Research Site 017
Newport Beach, California, 92663
CBCC Global Research Site: 012
Newport Beach, California, 92663
CBCC Global Research Site 013
Pasadena, California, 91107
CBCC Global Research Site 020
Pembroke Pines, Florida, 33029
CBCC Global Research Site 019
Petaluma, California, 94954
CBCC Global Research Site 015
San Diego, California, 92122
About this study
Official title: A Randomized ( 1:1), Double-Masked, Multi-Center, Two-Treatment, Single-Period, Parallel Design, Mutiple Dose Bioequivalence Study With Clinical End-Point of Bimatoprost Ophthalmic Solution 0.01% of Mankind Pharma Limited With LUMIGAN (Bimatoprost Ophthalmic Solution) 0.01% of Allergan, Inc., in Subjects With Chronic Open-Angle Glaucoma Or Ocular Hypertension in Both Eyes
This is a randomized, double-masked, 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 Mankind Pharma Limited, India
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. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0 at anytime of the day) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
Subjects will receive one drop of investigational product (either A or B) in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.
The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject 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 at six time points, i.e., at 00.00 hours (between 8:00am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours) and 08.00 hours ( at 8 hours after 00.00 hours) on Day 14 (week 2) and Day 42 (week 6) visits.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Test - Bimatoprost 0.01% Ophthalmic Solution, Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
- Medical subject headings
- Glaucoma, Open-Angle
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 ± 2 hours for 42 days.
Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)Drug
Subjects in the second arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | Experimental | Bimatoprost Pharmaceutical dosage form: Ophthalmic Solution Strength: 0.01% Manufactured by: Mankind Pharma Limited, India.
Intervention Drug: Test - Bimatoprost 0.01% Ophthalmic Solution Receives: Drug: Test - Bimatoprost 0.01% Ophthalmic Solution |
| LUMIGAN® 0.01% Ophthalmic Solution | Active comparator | LUMIGAN® ( Contains Bimatoprost) Pharmaceutical dosage form: Ophthalmic Solution Strength: 0.01% Manufactured by: Allergan, Inc.,
Intervention Drug: Reference - Bimatoprost 0.01% Ophthalmic Solution 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 Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Six Time Points
Change in mean difference in intraocular pressure (IOP) of both the eyes between the two treatment groups at six time points, i.e., at 00.00 hours (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours) on Day 14 (week 2) and Day 42 (week 6) visits.
Measured: Day 14 and 42 at 00.00 hours (between 8:00 AM and 10:00 AM), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours)
Secondary outcomes (1)
Safety and efficacy of Bimatoprost 0.01% Ophthalmic Solution
To monitor the adverse events and safety of the subjects and tolerability of Bimatoprost 0.01% Ophthalmic Solution
Measured: Safety will be evaluated throughout the study (6 weeks) and telephonic safety follow-up on day 49±3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start2 Oct 2021
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mankind Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890106
- Sponsor's protocol ID
- CBCC/2021/004
- Acronym
- Glaucoma
- Status last verified
- Dec 2022
- First submitted
- 12 May 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized ( 1:1), Double-Masked, Multi-Center, Two-Treatment, Single-Period, Parallel Design, Mutiple Dose Bioequivalence Study With Clinical End-Point of Bimatoprost Ophthalmic Solution 0.01% of Mankind Pharma Limited With LUMIGAN (Bimatoprost Ophthalmic Solution) 0.01% of Allergan, Inc., in Subjects With Chronic Open-Angle Glaucoma Or Ocular Hypertension in Both Eyes
- ClinicalTrials.gov ID
- NCT04890106
- Acronym / sponsor ID
- Glaucoma / CBCC/2021/004
- Conditions
- Glaucoma, Open-Angle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Mankind Pharma LimitedIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 18 May 2021 (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-masked, 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 Mankind Pharma Limited, India
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. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0 at anytime of the day) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
Subjects will receive one drop of investigational product (either A or B) in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.
The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject 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 at six time points, i.e., at 00.00 hours (between 8:00am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours) and 08.00 hours ( at 8 hours after 00.00 hours) on Day 14 (week 2) and Day 42 (week 6) visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | Experimental | Drug: Test - Bimatoprost 0.01% Ophthalmic SolutionBimatoprost Pharmaceutical dosage form: Ophthalmic Solution Strength: 0.01% Manufactured by: Mankind Pharma Limited, India. Intervention Drug: Test - Bimatoprost 0.01% Ophthalmic Solution |
| LUMIGAN® 0.01% Ophthalmic Solution | Active comparator | Drug: Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)LUMIGAN® ( Contains Bimatoprost) Pharmaceutical dosage form: Ophthalmic Solution Strength: 0.01% Manufactured by: Allergan, Inc., Intervention Drug: Reference - Bimatoprost 0.01% Ophthalmic Solution |
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 the protocol requirements
- Male or non-pregnant females aged ≥18 years having body mass index (BMI) ≥ 17 calculated as weight in kg/height in m2.
- Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
- Subjects requiring treatment of both the eyes and can discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo an appropriate washout period
- Adequate wash-out period prior to baseline of any ocular hypotensive medication as per the table below (In order 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 subjects must have discontinued all ocular hypotensive medications for the minimum washout period
Key exclusion criteria (21 listed)
- Hypersensitivity to Bimatoprost or related class of drugs or any of the excipients of the formulation
- Severe hepatic or renal impairment
- Current or history within two months prior to the 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 investigator's discretion) will be allowed provided other inclusion/exclusion criteria are met
- Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer
- Functionally significant visual field loss
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 ± 2 hours for 42 days. | Drug | Bimatoprost 0.01% Ophthalmic Solution |
| Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)Subjects in the second arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days. | Drug | LUMIGAN® 0.01% Ophthalmic Solution |
Primary outcome
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Six Time Points
Time frame: Day 14 and 42 at 00.00 hours (between 8:00 AM and 10:00 AM), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours)
Change in mean difference in intraocular pressure (IOP) of both the eyes between the two treatment groups at six time points, i.e., at 00.00 hours (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours) on Day 14 (week 2) and Day 42 (week 6) visits.
1 secondary outcome
Safety and efficacy of Bimatoprost 0.01% Ophthalmic Solution
Time frame: Safety will be evaluated throughout the study (6 weeks) and telephonic safety follow-up on day 49±3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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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.
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, run by Mankind Pharma Limited 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 21 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 13 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Six Time Points (time frame: Day 14 and 42 at 00.00 hours (between 8:00 AM and 10:00 AM), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 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 13 Dec 2022.