GlaucomaPhase 2NCT07168902
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 2 study testing BL1107 Low dose, BL1107 High dose and Timolol maleate 0.5% in people with Glaucoma, run by Bausch & Lomb Incorporated at 14 sites in United States.
Trial summary
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- BL1107 Low dose, BL1107 High dose and Timolol maleate 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 14 sitesUnited States
- Study dates
- 24 Oct 2025to 18 May 2026
- Phase
- Phase 2
- 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
- Ocular hypertension or primary open-angle glaucoma in each eye
Who cannot join
- History of orthostatic hypotension
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Contraindication to pupil dilation
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Global Research Management, Inc.
Glendale, California, 91204
Houston Eye Associates
Houston, Texas, 77025
Levenson Eye Associates
Jacksonville, Florida, 32204
Central Florida Eye Associates
Lakeland, Florida, 33805
Lee Shettle Eye and Hearing
Largo, Florida, 33773
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Eye Research Foundation
Newport Beach, California, 92663
California Eye Specialist Medical Group, LLC
Pasadena, California, 91107
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Heart of America Eye Care
Shawnee Mission, Kansas, 66204
About this study
Official title: A Phase 2 Evaluation of the Safety, Ocular Tolerability, and Efficacy of Topical Ophthalmic BL1107 Versus Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension
Read the detailed description
This study will evaluate the safety and efficacy of BL1107 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This is a randomized, double-masked, parallel comparison to evaluate two concentrations of BL1107 in both eyes compared with timolol 0.5% for 28 days.
- Conditions
- Glaucoma
- Being tested
- BL1107 Low dose, BL1107 High dose, Timolol maleate 0.5%
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL1107 Low doseDrug
Dosed twice daily for 28 days.
BL1107 High doseDrug
Dosed twice daily for 28 days.
Timolol maleate 0.5%Drug
Dosed twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| BL1107 Low dose | Experimental | Not described Receives: Drug: BL1107 Low dose |
| BL1107 High dose | Experimental | Not described Receives: Drug: BL1107 High dose |
| Timolol maleate 0.5% | Active comparator | Not described Receives: Drug: Timolol maleate 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.
Measured: Assessed at Day 28
Secondary outcomes (3)
Proportion of participants achieving ≥15-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.
Measured: Assessed at Day 28
Proportion of participants achieving ≥10-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.
Measured: Assessed at Day 28
Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit.
Measured: Assessed at Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start24 Oct 2025
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168902
- Sponsor's protocol ID
- RX01-BL1107-1201
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Evaluation of the Safety, Ocular Tolerability, and Efficacy of Topical Ophthalmic BL1107 Versus Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT07168902
- Acronym / sponsor ID
- RX01-BL1107-1201
- Conditions
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 11 Sep 2025 (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.
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension
Detailed description
This study will evaluate the safety and efficacy of BL1107 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This is a randomized, double-masked, parallel comparison to evaluate two concentrations of BL1107 in both eyes compared with timolol 0.5% for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BL1107 Low dose | Experimental | Drug: BL1107 Low dose |
| BL1107 High dose | Experimental | Drug: BL1107 High dose |
| Timolol maleate 0.5% | Active comparator | Drug: Timolol maleate 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ocular hypertension or primary open-angle glaucoma in each eye
Key exclusion criteria (4 listed)
- History of orthostatic hypotension
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Contraindication to pupil dilation
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 |
|---|---|---|
| BL1107 Low doseDosed twice daily for 28 days. | Drug | BL1107 Low dose |
| BL1107 High doseDosed twice daily for 28 days. | Drug | BL1107 High dose |
| Timolol maleate 0.5%Dosed twice daily for 28 days. | Drug | Timolol maleate 0.5% |
Primary outcome
Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.
Time frame: Assessed at Day 28
3 secondary outcomes
Proportion of participants achieving ≥15-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.
Time frame: Assessed at Day 28
Proportion of participants achieving ≥10-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.
Time frame: Assessed at Day 28
Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit.
Time frame: Assessed at Day 28
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 22 Jul 2026.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL1107 Low dose, BL1107 High dose and Timolol maleate 0.5% in people with Glaucoma, run by Bausch & Lomb Incorporated at 14 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 1 inclusion and 4 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 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?
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?
Change from baseline in visual field mean deviation in the study eye at Day 28/Exit. (time frame: Assessed at Day 28). 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 22 Jul 2026.