Dry Eye DiseasePhase 2NCT06370039
Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease
A Phase 2 study testing INV-102 in people with Dry Eye Disease, run by Invirsa, Inc. at 1 site in United States.
Trial summary
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- INV-102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to 3 Jul 2024
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥18 and <75 years of age
- Presence of moderate to severe dry eye disease (DED) in at least one eye
Who cannot join
- Presently using prescription eyedrops, except those used for dry eye disease, which must be discontinued 4 weeks prior
- Use of over-the-counter (OTC) eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- History or evidence of ocular infection within the previous 30 days
- Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
- Allergic conjunctivitis requiring treatment within 30 days
- Unable to discontinue contact lens wear for 2 weeks prior and for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate to Severe Dry Eye Disease
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- INV-102, Vehicle
- Keywords
- Dry Eye, Keratoconjunctivitis sicca
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-102Drug
INV-102 Ophthalmic Solution
VehicleDrug
Vehicle Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| INV-102 | Experimental | INV-102 0.7% ophthalmic solution administered for 4 weeks (twice daily [BID] for 2 weeks, then once daily [QD] for an additional 2 weeks) Receives: Drug: INV-102 |
| Vehicle | Placebo comparator | Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks) Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale
Corneal fluorescein staining assessment will be performed using the NEI grading system to score each of 5 corneal zones (central, superior, lateral, medial, inferior) on a 0 to 3 scale (with a total score of 0 to 15). Higher scores indicate more corneal damage.
Measured: Baseline to Day 29
Secondary outcomes (1)
Percentage of eyes with complete clearing of central corneal fluorescein staining
Measured: Baseline to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start27 Mar 2024
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invirsa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Robert Shalwitz, MD, Study chair, Invirsa, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370039
- Sponsor's protocol ID
- INV-102-CS-003
- Other IDs
- 75A50120C00171
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2024
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate to Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06370039
- Acronym / sponsor ID
- INV-102-CS-003
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye, Keratoconjunctivitis sicca
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Invirsa, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 17 Apr 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.
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease.
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 |
|---|---|---|
| INV-102 | Experimental | Drug: INV-102INV-102 0.7% ophthalmic solution administered for 4 weeks (twice daily [BID] for 2 weeks, then once daily [QD] for an additional 2 weeks) |
| Vehicle | Placebo comparator | Drug: VehicleVehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects ≥18 and <75 years of age
- Presence of moderate to severe dry eye disease (DED) in at least one eye
Key exclusion criteria (6 listed)
- Presently using prescription eyedrops, except those used for dry eye disease, which must be discontinued 4 weeks prior
- Use of over-the-counter (OTC) eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- History or evidence of ocular infection within the previous 30 days
- Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
- Allergic conjunctivitis requiring treatment 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 |
|---|---|---|
| INV-102INV-102 Ophthalmic Solution | Drug | INV-102 |
| VehicleVehicle Ophthalmic Solution | Drug | Vehicle |
Primary outcome
Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale
Time frame: Baseline to Day 29
Corneal fluorescein staining assessment will be performed using the NEI grading system to score each of 5 corneal zones (central, superior, lateral, medial, inferior) on a 0 to 3 scale (with a total score of 0 to 15). Higher scores indicate more corneal damage.
1 secondary outcome
Percentage of eyes with complete clearing of central corneal fluorescein staining
Time frame: Baseline to 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 18 Sep 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.
Robert Shalwitz, MD study chair
Invirsa, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INV-102 in people with Dry Eye Disease, run by Invirsa, Inc. at 1 site 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 2 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale (time frame: Baseline to 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 18 Sep 2026.