Dry Eye DiseasePhase 2NCT07128628
A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
A Phase 2 study testing Lifitegrast/Perfluorohexyloctane Fixed Dose Combination, Lifitegrast and Perfluorohexyloctane in people with Dry Eye Disease, run by Bausch & Lomb Incorporated at 32 sites in United States.
Trial summary
A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease 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?
- Lifitegrast/Perfluorohexyloctane Fixed Dose Combination, Lifitegrast and Perfluorohexyloctane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 443 participants
- Where
- 32 sitesUnited States
- Study dates
- 24 Oct 2025to 28 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
- This study will include subjects who meet all of the following inclusion criteria:
- Voluntarily provide written informed consent
- ≥18 years of age
- Subject-reported history of DED OU for at least 6 months
- Same eye satisfies the criteria for dry eye signs at both screening and baseline/randomization
- The criteria for dry eye symptoms are met at both screening and baseline/randomization
- As needed (PRN) or scheduled use of non-prescription (OTC) artificial tear, gels, or lubricants for symptoms of dry eye within the past 30 days
- Able and willing to follow instructions, including participation in all trial assessments and visits
Who cannot join
- This study will exclude subjects who meet any of the following exclusion criteria (Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study):
- Known allergy or sensitivity to any study treatment (or any of its components)
- Best-corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or worse (50 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; Snellen equivalent score of 20/100 or worse) at Visit 1 (Screening) or Visit 2 (baseline/randomization)
- Any clinically significant (CS) ocular surface slit-lamp findings at Visit 1 (Screening) or Visit 2 (baseline/randomization), or findings that may interfere with trial parameters in the opinion of the Investigator.
- Use of any of any ocular therapies within 30 days.
- Unable or unwilling to stop current topical dry eye treatments
- Additional criteria per protocol
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Vance Thompson Vision - Alexandria
Alexandria, Minnesota, 56308
Asheville Eye Associates
Asheville, North Carolina, 28803
Midwest Cornea Associates LLC
Carmel, Indiana, 46032
Scott & Christie Eyecare Associates - The Surgery Center at Cranberry
Cranberry Township, Pennsylvania, 16066
Segal Drug Trials/Office of Bruce A Segal, MD
Delray Beach, Florida, 33484
Opthalmic consultants of Long Island
Garden City, New York, 11530
Oculus Research
Garner, North Carolina, 27529
Global Research Management, Inc.
Glendale, California, 91204
Intouch Clinical Research Center
Houston, Texas, 77034
Bowden Eye and Associates
Jacksonville, Florida, 32256
Insight Eyecare Specialties, Inc.
Kansas City, Missouri, 64111
Moyes Eye Center, P.C.
Kansas City, Missouri, 64154
Lake Travis Eye and Laser Center
Lakeway, Texas, 78738
Shettle Eye Research, Inc
Largo, Florida, 33773
SoCal Eye - Lakewood Clinic
Long Beach, California, 90805
Complete Eye Care of Medina
Medina, Minnesota, 55340
Southern College of Optometry
Memphis, Tennessee, 38104
Total Eye Care PA
Memphis, Tennessee, 38119
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
Eye Research Foundation, Inc.
Newport Beach, California, 92663
Eye Doctors of Arizona, PLLC
Phoenix, Arizona, 85028
Kannarr Eye Care, LLC
Pittsburg, Kansas, 66762
Insight Research Clinic LLC.
Powell, Ohio, 43065
Rochester Ophthalmological Group,PC
Rochester, New York, 14618
CORE Inc.
Shelby, North Carolina, 28150
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167
Ophthalmology Consultants, Ltd.
St Louis, Missouri, 63131
Wolstan and Goldberg Eye Associates
Torrance, California, 90505
West Bay Eye Associates
Warwick, Rhode Island, 02888
Comprehensive Eye Care Ltd.
Washington, Missouri, 63090
Vance Thompson Vision - Fargo, ND
West Fargo, North Dakota, 58078
About this study
Official title: A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
- Conditions
- Dry Eye Disease
- Being tested
- Lifitegrast/Perfluorohexyloctane Fixed Dose Combination, Lifitegrast, Perfluorohexyloctane, Vehicle
- 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.
Lifitegrast/Perfluorohexyloctane Fixed Dose CombinationDrug
Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
LifitegrastDrug
Topical ocular drop of lifitegrast administered for 4 weeks
PerfluorohexyloctaneDrug
Topical ocular drop of perfluorohexyloctane administered for 4 weeks
VehicleDrug
Topical ocular drop with no active ingredients administered for 4 weeks
VehicleDrug
Topical ocular drop with no active ingredients administered for 4 weeks
VehicleDrug
Topical ocular drop with no active ingredients administered for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Lifitegrast/Perfluorohexyloctane Fixed Dose Combination |
| Arm 2 | Active comparator | Not described Receives: Drug: Lifitegrast |
| Arm 3 | Active comparator | Not described Receives: Drug: Perfluorohexyloctane |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Vehicle |
| Arm 5 | Placebo comparator | Not described Receives: Drug: Vehicle |
| Arm 6 | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total corneal fluorescein staining change from baseline
Measured: Baseline, day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start24 Oct 2025
- Primary completion28 May 2026
- Study completion28 May 2026
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 443 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
- NCT07128628
- Sponsor's protocol ID
- BL-RX01-OPUSNG-1201
- Status last verified
- Jul 2026
- First submitted
- 6 Aug 2025
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07128628
- Acronym / sponsor ID
- BL-RX01-OPUSNG-1201
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 19 Aug 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.
A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Lifitegrast/Perfluorohexyloctane Fixed Dose Combination |
| Arm 2 | Active comparator | Drug: Lifitegrast |
| Arm 3 | Active comparator | Drug: Perfluorohexyloctane |
| Arm 4 | Placebo comparator | Drug: Vehicle |
| Arm 5 | Placebo comparator | Drug: Vehicle |
| Arm 6 | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily provide written informed consent
- ≥18 years of age
- Subject-reported history of DED OU for at least 6 months
- Same eye satisfies the criteria for dry eye signs at both screening and baseline/randomization
- The criteria for dry eye symptoms are met at both screening and baseline/randomization
Key exclusion criteria (7 listed)
- This study will exclude subjects who meet any of the following exclusion criteria (Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study):
- Known allergy or sensitivity to any study treatment (or any of its components)
- Best-corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or worse (50 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; Snellen equivalent score of 20/100 or worse) at Visit 1 (Screening) or Visit 2 (baseline/randomization)
- Any clinically significant (CS) ocular surface slit-lamp findings at Visit 1 (Screening) or Visit 2 (baseline/randomization), or findings that may interfere with trial parameters in the opinion of the Investigator.
- Use of any of any ocular therapies within 30 days.
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 |
|---|---|---|
| Lifitegrast/Perfluorohexyloctane Fixed Dose CombinationTopical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks | Drug | Arm 1 |
| LifitegrastTopical ocular drop of lifitegrast administered for 4 weeks | Drug | Arm 2 |
| PerfluorohexyloctaneTopical ocular drop of perfluorohexyloctane administered for 4 weeks | Drug | Arm 3 |
| VehicleTopical ocular drop with no active ingredients administered for 4 weeks | Drug | Arm 4 |
| VehicleTopical ocular drop with no active ingredients administered for 4 weeks | Drug | Arm 5 |
| VehicleTopical ocular drop with no active ingredients administered for 4 weeks | Drug | Arm 6 |
Primary outcome
Total corneal fluorescein staining change from baseline
Time frame: Baseline, day 29
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 14 Jul 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 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 Lifitegrast/Perfluorohexyloctane Fixed Dose Combination, Lifitegrast and Perfluorohexyloctane in people with Dry Eye Disease, run by Bausch & Lomb Incorporated at 32 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 8 inclusion and 7 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 14 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 32 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. Some participants in this study may receive a placebo. 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?
Total corneal fluorescein staining change from baseline (time frame: Baseline, day 29). 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 14 Jul 2026.