Dry EyePhase 4TLWENCT06671041
Treating Lid Wiper Epitheliopathy
A Phase 4 study testing Preservative Free eye drop in people with Dry Eye and Visual Acuity, run by Southern College of Optometry at 4 sites in United States.
Trial summary
Lid wiper epitheliopathy (LWE) is a relatively new entry into the abundance of clinical ocular surface health signs. LWE was first reported in 2002 as a potential cause for dry eye disease (DED) (Korb et al., 2002). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Visual Acuity
- What is being tested?
- Preservative Free eye drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 May 2024to 30 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- best corrected visual acuity (BCVA) of 20/100 or better
- who have symptomatic DED will be recruited (SPEED ≥6)
- Subjects will also be required to have a LWE score of 1.0 or greater to be included in the study.
- Subjects will be required to discontinue contact lens wear throughout the study.
Who cannot join
- known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome),
- have a history of ocular surgery within the past 12 months, have a history of severe ocular trauma, active ocular infection or inflammation,
- are currently using Accutane or ocular medications, or if they are pregnant or breast feeding.
- Artificial tear use will be discontinued at least one week prior to enrollment. Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study will be excluded.
- Subjects that have had a physical meibomian gland treatment withing 1 month of enrollment (iLux, Lipiflow, etc.) will be excluded.
- Subjects will not be allowed to use any eye drops beyond their assignment during the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Complete Eye Care of Medina
Medina, Minnesota, 55340
The Southern College of Optometry
Memphis, Tennessee, 38104
Maitland Vision Center
Orlando, Florida, 32751
Montaquila
Warwick, Rhode Island, 02888
About this study
Official title: Treating Lid Wiper Epitheliopathy With Perfluorohexyloctane
Lid wiper epitheliopathy (LWE) is a relatively new entry into the abundance of clinical ocular surface health signs. LWE was first reported in 2002 as a potential cause for dry eye disease (DED) (Korb et al., 2002). This clinical sign is visualised by everting the eyelid after a dye has been applied and observing the palpebral conjunctiva proximal to the eyelashes
Read the detailed description
Lid wiper epitheliopathy (LWE) is a relatively new entry into the abundance of clinical ocular surface health signs. LWE was first reported in 2002 as a potential cause for dry eye disease. This clinical sign is visualised by everting the eyelid after a dye has been applied and observing the palpebral conjunctiva proximal to the eyelashes. An observable line at the mucocutaneous junction, called the line of Marx, is present in all eyelids and any further staining of the tissue in the palpebral marginal conjunctiva can be regarded as LWE. LWE has been described as a micro-trauma caused by inadequate ocular lubrication and/or excessive friction. The lid wiper is one of the most sensitive conjunctival tissue areas of the ocular surface and upper eyelid LWE has been reported to be highly correlated to ocular surface discomfort and DED
Korb, theorised some plausible aetiologies for LWE. They were all ultimately linked to frictional related damaged initiated by 1) tear film dysfunction not including tear volume (since normal Schirmer testing was an inclusion in their study), 2) localised disorders of the lid wiper itself, 3) aberrant blinking, 4) ocular surface abnormalities at the cellular level (subclinical) to initiate excessive localised trauma, and 5) conditions that would lead to inflammation of the lid wiper.
The TFOS executive summary determined that a complete review of the clinical trials revealed a potential link of LWE to DED and suggested that future trials be performed to make conclusions as to which interventions might deliver the greatest impact Because LWE has been linked to DED, most of the proposed treatment strategies to relieve LWE have paralleled after treatments for DED and MGD. Treatment options fall into several categories. They are as follows: blinking, tear supplements and lubricants, tear retention agents, tear stimulants (secretagogues), biological tear substitutes, anti-inflammatory therapy, essential fatty acids, treatment of MGD and environmental strategies (including in-office treatments).
Excessive tear evaporation due to a deficient lipid layer is believed to be the most common cause of DED, and most evaporative DED is associated with MGD. Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb) is a preservative-free eye drop that has demonstrated the ability to form a long-lasting barrier that inhibits evaporation in preclinical studies. FDA approval of PFHO was based on results from 2 pivotal clinical trials (GOBI [NCT04139798] and MOJAVE [NCT04567329]) in patients with DED and clinical signs of MGD, which demonstrated consistent improvements in both signs and symptoms of DED (Karpecki et al., 2023; Vittitow et al., 2023). PFHO is the first and only FDA-approved eye drop that directly targets tear
- Conditions
- Dry Eye, Visual Acuity
- Being tested
- Preservative Free eye drop
- Keywords
- Optometry, Dry Eye, Lens Wiper
- 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.
Preservative Free eye dropDrug
Participants were required to use a lubricating eye drop
| Study group | Role | What they receive |
|---|---|---|
| Preservative-free eye drop | Experimental | Participants were assigned to use a preservative-free eye drop 4X a day Receives: Drug: Preservative Free eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
VAS on a scale from 0-100 will be reported at baseline, 2 weeks, 1 month and 2 months and recoreded to see if there is a reduction in the percentage of subjects with a reduction in VAS scores for eye dryness, eye scratchiness, eye gritty/sandy feeling, eye irritation/soreness, eye burning/stinging, tired eyes, and itchy eyes (0-100)
Measured: 2-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 May 2024
- Primary completion14 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671041
- Sponsor's protocol ID
- IRB-2023-03-01AS
- Acronym
- TLWE
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lievens C, Pucker AD, Franklin Q, Montaquila SM, Giedd B, Wesley G, Bromley M, Coker Z, Meyers J, Vianya-Estopa M. Investigating the Effect of Reducing the Signs and Symptoms of Lid Wiper Epitheliopathy in Patients With Dry Eye Disease With Perfluorohexyloctane. Curr Ther Res Clin Exp. 2025 Mar 20;102:100786. doi: 10.1016/j.curtheres.2025.100786. eCollection 2025.
PubMed 40276144
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Lid Wiper Epitheliopathy With Perfluorohexyloctane
- ClinicalTrials.gov ID
- NCT06671041
- Acronym / sponsor ID
- TLWE / IRB-2023-03-01AS
- Conditions
- Dry Eye, Visual Acuity
- Keywords
- Optometry, Dry Eye, Lens Wiper
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 27 May 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 4 Nov 2024 (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.
Lid wiper epitheliopathy (LWE) is a relatively new entry into the abundance of clinical ocular surface health signs. LWE was first reported in 2002 as a potential cause for dry eye disease (DED) (Korb et al., 2002). This clinical sign is visualised by everting the eyelid after a dye has been applied and observing the palpebral conjunctiva proximal to the eyelashes
Detailed description
Lid wiper epitheliopathy (LWE) is a relatively new entry into the abundance of clinical ocular surface health signs. LWE was first reported in 2002 as a potential cause for dry eye disease. This clinical sign is visualised by everting the eyelid after a dye has been applied and observing the palpebral conjunctiva proximal to the eyelashes. An observable line at the mucocutaneous junction, called the line of Marx, is present in all eyelids and any further staining of the tissue in the palpebral marginal conjunctiva can be regarded as LWE. LWE has been described as a micro-trauma caused by inadequate ocular lubrication and/or excessive friction. The lid wiper is one of the most sensitive conjunctival tissue areas of the ocular surface and upper eyelid LWE has been reported to be highly correlated to ocular surface discomfort and DED
Korb, theorised some plausible aetiologies for LWE. They were all ultimately linked to frictional related damaged initiated by 1) tear film dysfunction not including tear volume (since normal Schirmer testing was an inclusion in their study), 2) localised disorders of the lid wiper itself, 3) aberrant blinking, 4) ocular surface abnormalities at the cellular level (subclinical) to initiate excessive localised trauma, and 5) conditions that would lead to inflammation of the lid wiper.
The TFOS executive summary determined that a complete review of the clinical trials revealed a potential link of LWE to DED and suggested that future trials be performed to make conclusions as to which interventions might deliver the greatest impact Because LWE has been linked to DED, most of the proposed treatment strategies to relieve LWE have paralleled after treatments for DED and MGD. Treatment options fall into several categories. They are as follows: blinking, tear supplements and lubricants, tear retention agents, tear stimulants (secretagogues), biological tear substitutes, anti-inflammatory therapy, essential fatty acids, treatment of MGD and environmental strategies (including in-office treatments).
Excessive tear evaporation due to a deficient lipid layer is believed to be the most common cause of DED, and most evaporative DED is associated with MGD. Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb) is a preservative-free eye drop that has demonstrated the ability to form a long-lasting barrier that inhibits evaporation in preclinical studies. FDA approval of PFHO was based on results from 2 pivotal clinical trials (GOBI [NCT04139798] and MOJAVE [NCT04567329]) in patients with DED and clinical signs of MGD, which demonstrated consistent improvements in both signs and symptoms of DED (Karpecki et al., 2023; Vittitow et al., 2023). PFHO is the first and only FDA-approved eye drop that directly targets tear
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preservative-free eye drop | Experimental | Drug: Preservative Free eye dropParticipants were assigned to use a preservative-free eye drop 4X a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥18 years of age
- best corrected visual acuity (BCVA) of 20/100 or better
- who have symptomatic DED will be recruited (SPEED ≥6)
- Subjects will also be required to have a LWE score of 1.0 or greater to be included in the study.
- Subjects will be required to discontinue contact lens wear throughout the study.
Key exclusion criteria (6 listed)
- known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome),
- have a history of ocular surgery within the past 12 months, have a history of severe ocular trauma, active ocular infection or inflammation,
- are currently using Accutane or ocular medications, or if they are pregnant or breast feeding.
- Artificial tear use will be discontinued at least one week prior to enrollment. Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study will be excluded.
- Subjects that have had a physical meibomian gland treatment withing 1 month of enrollment (iLux, Lipiflow, etc.) will be excluded.
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 |
|---|---|---|
| Preservative Free eye dropParticipants were required to use a lubricating eye drop | Drug | Preservative-free eye drop |
Primary outcome
VAS
Time frame: 2-Months
VAS on a scale from 0-100 will be reported at baseline, 2 weeks, 1 month and 2 months and recoreded to see if there is a reduction in the percentage of subjects with a reduction in VAS scores for eye dryness, eye scratchiness, eye gritty/sandy feeling, eye irritation/soreness, eye burning/stinging, tired eyes, and itchy eyes (0-100)
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 25 Feb 2025.
- Derived from this study: PubMed 40276144Lievens C, Pucker AD, Franklin Q, Montaquila SM, Giedd B, Wesley G, Bromley M, Coker Z, Meyers J, Vianya-Estopa M. Investigating the Effect of Reducing the Signs and Symptoms of Lid Wiper Epitheliopathy in Patients With Dry Eye Disease With Perfluorohexyloctane. Curr Ther Res Clin Exp. 2025 Mar 20;102:100786. doi: 10.1016/j.curtheres.2025.100786. eCollection 2025.
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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 Preservative Free eye drop in people with Dry Eye and Visual Acuity, run by Southern College of Optometry 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 6 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 25 Feb 2025. 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?
VAS (time frame: 2-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06671041, which also lists 1 linked publication.
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 25 Feb 2025.