Dry Eye DiseasePhase 2BRIGHTNCT07778888
BL1107 Response and Intensity Guided Dosing for Hyperemia Resolution Trial
A Phase 2 study testing BL1107 in people with Dry Eye Disease, run by Bausch & Lomb Incorporated.
Trial summary
Trial RX01-BL1107-1202 is designed to identify the lowest effective concentration of BL1107 required for complete resolution of conjunctival hyperemia in participants with DED. Participants will be masked to concentration of BL1107 received. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- BL1107
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Feb 2027
- Phase
- Phase 2
- 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
- Documented diagnosis of dry eye disease
- Conjunctival hyperemia in both eyes, without clinical signs of infection or allergic conjunctivitis
Who cannot join
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Additional criteria per protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 2a Masked Trial to Identify the Lowest Effective Concentration of BL1107 for Conjunctival Hyperemia in Patients With Dry Eye Disease
Trial RX01-BL1107-1202 is designed to identify the lowest effective concentration of BL1107 required for complete resolution of conjunctival hyperemia in participants with DED. Participants will be masked to concentration of BL1107 received.
- Conditions
- Dry Eye Disease
- Being tested
- BL1107
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL1107Drug
BL1107 topical ocular solution
| Study group | Role | What they receive |
|---|---|---|
| BL1107 is sterile ophthalmic solution to be administered at varying concentrations | Experimental | Not described Receives: Drug: BL1107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Part 1: Proportion of participants with complete resolution in conjunctival hyperemia at 30 minutes, in each evaluated concentration of BL1107.
Measured: Assessed at 30 minutes
Primary Part 2: Proportion of participants with complete resolution in conjunctival hyperemia at 8 hours, in each evaluated concentration of BL1107
Measured: Assessed at 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778888
- Sponsor's protocol ID
- RX01-BL1107-1202
- Acronym
- BRIGHT
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Masked Trial to Identify the Lowest Effective Concentration of BL1107 for Conjunctival Hyperemia in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07778888
- Acronym / sponsor ID
- BRIGHT / RX01-BL1107-1202
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Aug 2026 (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.
Trial RX01-BL1107-1202 is designed to identify the lowest effective concentration of BL1107 required for complete resolution of conjunctival hyperemia in participants with DED. Participants will be masked to concentration of BL1107 received.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BL1107 is sterile ophthalmic solution to be administered at varying concentrations | Experimental | Drug: BL1107 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented diagnosis of dry eye disease
- Conjunctival hyperemia in both eyes, without clinical signs of infection or allergic conjunctivitis
Key exclusion criteria (3 listed)
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Additional criteria per protocol
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 |
|---|---|---|
| BL1107BL1107 topical ocular solution | Drug | BL1107 is sterile ophthalmic solution to be administered at varying concentrations |
Primary outcome
Primary Part 1: Proportion of participants with complete resolution in conjunctival hyperemia at 30 minutes, in each evaluated concentration of BL1107.
Time frame: Assessed at 30 minutes
Primary Part 2: Proportion of participants with complete resolution in conjunctival hyperemia at 8 hours, in each evaluated concentration of BL1107
Time frame: Assessed at 8 hours
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 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL1107 in people with Dry Eye Disease, run by Bausch & Lomb Incorporated.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Johnson Varughese (9089271162, Johnson.Varughese@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Part 1: Proportion of participants with complete resolution in conjunctival hyperemia at 30 minutes, in each evaluated concentration of BL1107. (time frame: Assessed at 30 minutes). The study lists 2 primary outcomes in all. 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 21 Aug 2026.