Dry Eye Disease (DED)Phase 4NCT07243275
SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
A Phase 4 study testing SYSTANE® PRO and MIEBO™ (Perfluorohexyloctane, PFHO) in people with Dry Eye Disease (DED), run by Indiana University at 4 sites in United States.
Trial summary
This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- SYSTANE® PRO and MIEBO™ (Perfluorohexyloctane, PFHO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Feb 2026to 28 Jul 2026
- Phase
- Phase 4
- 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
- Adults>=18 years of age
- Corrected visual acuity of 20/100 or better in both eyes
- Ocular Surface Disease Index [OSDI] scores between 23 and 50 units [inclusive]
- Tear break up time score of <=5 seconds in both eyes
- Schirmer I test (without anesthesia) >=5 mm in both eyes
Who cannot join
- Discontinue contact lens wear starting 7 days prior and throughout the study
- Artificial tears and warm compresses should not be used for at least one week prior to enrollment and throughout the study
- Systemic health conditions that are known to alter tear film physiology(e.g., primary and secondary Sjogren's syndrome)
- History of ocular surgery within the past 12 months
- History of severe ocular trauma, active ocular infection or inflammation, have ever used Accutane or are currently using ocular medications.
- Women who are pregnant or breast feeding(self report)
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- Subjects with a condition or in a situation, which in the investigator's opinion, may put the subject at significant rist, may confound the study results, or may significantly interfere with their participation in the study
- Subjects will not be allowed to use any other topical eye drops or other dry eye treatments beyond their assignment during the study
- Participants in clinical trial or study using a device, topical, or oral therapeutic in the past 3 months of enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana Universtiy School of Optometry
Bloomington, Indiana, 47408
Southern College of Optometry
Memphis, Tennessee, 38104
Eye Research Foundation
Newport Beach, California, 92663
Kannarr Eye Care
Pittsburg, Kansas, 66762
About this study
Official title: Comparing the Efficacy of SYSTANE® PRO to MIEBO™ for the Treatment of Dry Eye Disease
This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- SYSTANE® PRO, MIEBO™ (Perfluorohexyloctane, PFHO)
- 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.
SYSTANE® PRODrug
SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
MIEBO™ (Perfluorohexyloctane, PFHO)Drug
Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.
| Study group | Role | What they receive |
|---|---|---|
| SYSTANE® PRO | Active comparator | SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar. Receives: Drug: SYSTANE® PRO |
| MIEBO™ (Perfluorohexyloctane, PFHO) | Active comparator | Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop. Receives: Drug: MIEBO™ (Perfluorohexyloctane, PFHO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI Scores
Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 1-month visit (0-100 scale).
Measured: Between group difference at 1 month
Secondary outcomes (2)
Between-group difference in mean change from baseline in Eye Dryness Visual Analog (VAS) Scores at the 1-month visit
Between-group difference in mean change from baseline in Eye Dryness Visual Analog (VAS) Scores at the 1-month visit
Measured: Between-group difference in mean change from baseline at 1 month
Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 2 weeks visit
Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 2 weeks visit
Measured: Between-group difference in mean change from baseline at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start18 Feb 2026
- Primary completion28 Jul 2026
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Anna Tichenor, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243275
- Sponsor's protocol ID
- 28245
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of SYSTANE® PRO to MIEBO™ for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07243275
- Acronym / sponsor ID
- 28245
- Conditions
- Dry Eye Disease (DED)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 21 Nov 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.
This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYSTANE® PRO | Active comparator | Drug: SYSTANE® PROSYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar. |
| MIEBO™ (Perfluorohexyloctane, PFHO) | Active comparator | Drug: MIEBO™ (Perfluorohexyloctane, PFHO)Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults>=18 years of age
- Corrected visual acuity of 20/100 or better in both eyes
- Ocular Surface Disease Index [OSDI] scores between 23 and 50 units [inclusive]
- Tear break up time score of <=5 seconds in both eyes
- Schirmer I test (without anesthesia) >=5 mm in both eyes
Key exclusion criteria (9 listed)
- Discontinue contact lens wear starting 7 days prior and throughout the study
- Artificial tears and warm compresses should not be used for at least one week prior to enrollment and throughout the study
- Systemic health conditions that are known to alter tear film physiology(e.g., primary and secondary Sjogren's syndrome)
- History of ocular surgery within the past 12 months
- History of severe ocular trauma, active ocular infection or inflammation, have ever used Accutane or are currently using ocular medications.
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 |
|---|---|---|
| SYSTANE® PROSYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar. | Drug | SYSTANE® PRO |
| MIEBO™ (Perfluorohexyloctane, PFHO)Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop. | Drug | MIEBO™ (Perfluorohexyloctane, PFHO) |
Primary outcome
OSDI Scores
Time frame: Between group difference at 1 month
Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 1-month visit (0-100 scale).
2 secondary outcomes
Between-group difference in mean change from baseline in Eye Dryness Visual Analog (VAS) Scores at the 1-month visit
Time frame: Between-group difference in mean change from baseline at 1 month
Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 2 weeks visit
Time frame: Between-group difference in mean change from baseline at 2 weeks
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 19 Aug 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SYSTANE® PRO and MIEBO™ (Perfluorohexyloctane, PFHO) in people with Dry Eye Disease (DED), run by Indiana University at 4 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 5 inclusion and 9 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
OSDI Scores (time frame: Between group difference at 1 month). 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 19 Aug 2026.