New Preservative-Free eye drop could match leading glaucoma treatment
NCT ID NCT07661329
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether a preservative-free version of bimatoprost eye drops works as well as the standard Lumigan drops for lowering eye pressure. About 600 adults with primary open-angle glaucoma or ocular hypertension in both eyes will receive either the new formulation or Lumigan. The study measures eye pressure over time to see if the new drops are non-inferior.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bimatoprost ophthalmic solution 0.01%
- What this could lead to
- If successful, this could offer a preservative-free alternative to a standard glaucoma treatment, potentially reducing side effects for patients.
- What could go wrong
- This is a non-inferiority trial, so the new formulation may prove no better than the existing drug. Results are limited to eye pressure reduction, not long-term vision outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects willing and able to provide voluntary informed consent and to follow protocol requirements. * Male or females aged ≥18 years. * Subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) in both eyes * Subjects requiring treatment in both the 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 (Day 0) of any ocular hypotensive medications * Baseline (Day 0/hour 0) IOP ≥22 mm Hg and ≤ 34 mm Hg in both eyes, with difference between the IOP in left and right eyes not being more than 5 mm Hg * Subjects' IOP is likely to be controlled with monotherapy. * Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart. * Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the study participation) practicing any of the following acceptable methods of contraception: 1. 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. 2. Intrauterine device (IUD) or intrauterine system (IUS) 3. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) 4. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject) 5. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation 6. Total abstinence; partial abstinence is not acceptable * No history of addiction to any recreational drug or drug dependence or alcohol addiction Exclusion Criteria: * Female subjects with positive pregnancy test or lactating or planning a pregnancy. * Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation or benzalkonium chloride. * Current or history of severe hepatic or renal impairment. * Current or history within 3 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 will be allowed provided that the other inclusion/exclusion criteria are met). * Current corneal abnormalities that would prevent accurate IOP readings with tonometer. * Functionally significant visual field loss as determined by perimetry. * Subjects 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 21 days prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid. * Use within 21 days prior to baseline of a systemic corticosteroid. * Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid. * Underwent within 3 months prior to baseline any other intraocular surgery (e.g., cataract surgery). Underwent any filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty) within 3 months prior to baseline or refractive surgery at any time. * Subjects with a history of non-responder to 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 glaucoma with a cup/disk ratio greater than 0.8 (not including physiological cupping in the Investigators' opinion). * Chronic use of any systemic medication that may affect IOP with less than 2 months stable dosing regimen (i.e., sympathomimetic agents, betaadrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.) * Central Corneal thickness (CCT) \<480 microns or \>620 microns for study eye. * Known history or presence of any uncontrolled systemic disease * History of recurrent ocular seasonal allergies within past 2 years prior to screening. * 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 cases of active Hepatitis B virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection. * Subjects with aphakia or history of herpes simplex keratitis
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
16 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Advanced research, LLC
NOT_YET_RECRUITINGBoynton Beach, Florida, 33437, United States
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Advanced research, LLC
NOT_YET_RECRUITINGWeston, Florida, 33326, United States
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Clayton Eye Clinical Research
NOT_YET_RECRUITINGMorrow, Georgia, 30260, United States
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Coastal Research Associates, LLC
NOT_YET_RECRUITINGRoswell, Georgia, 30076, United States
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Eye research foundation, Inc.
RECRUITINGNewport Beach, California, 92663, United States
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Houston Eye Associates
NOT_YET_RECRUITINGHouston, Texas, 77008, United States
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National Clinical Trials
NOT_YET_RECRUITINGBeverly Hills, California, 90210, United States
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North Bay Eye Associates
NOT_YET_RECRUITINGPetaluma, California, 94954, United States
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Ophthalmology associate (Eye care)
NOT_YET_RECRUITINGSt Louis, Missouri, 63131, United States
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Quantum clinical trials
NOT_YET_RECRUITINGMiami Beach, Florida, 33140, United States
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R and R eye research
NOT_YET_RECRUITINGSan Antonio, Texas, 78229, United States
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Rochester Ophthalmological Group
NOT_YET_RECRUITINGRochester, New York, 14618, United States
Contact Email: •••••@•••••
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Tekwani vision center
NOT_YET_RECRUITINGSt Louis, Missouri, 63128, United States
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The eye care institute
NOT_YET_RECRUITINGLouisville, Kentucky, 40206, United States
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United medical research institute
NOT_YET_RECRUITINGInglewood, California, 90301, United States
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Visionary Eye Research Institute
NOT_YET_RECRUITINGNewport Beach, California, 92663, United States
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Other studies related to the condition(s) this trial covers.
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- Could a daily reading drill restore lost reading skills in glaucoma?
- New surgical tool aims to lower eye pressure in glaucoma patients
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- New eye drug targets fluid buildup to fight glaucoma