Dry Eye DiseasePhase 1/2NCT05586152
Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease
A Phase 1/2 study testing INV-102 in people with Dry Eye Disease, run by Invirsa, Inc. at 1 site in United States.
Trial summary
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an… 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?
- INV-102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2022to 2 May 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy male or female subject ≥18 years of age
- Presence of moderate DED in at least one eye
Who cannot join
- Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior
- Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- External eye disease except primary DED
- Systemic disease associated with DED
- History or evidence of ocular infection within the previous 30 days
- History or evidence of ocular herpes simplex or ocular herpes zoster
- Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Multiple Ascending Dose (Part 1) and Optional Dose Expansion (Part 2) Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate Symptomatic Dry Eye Disease
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic 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 0.1% Twice daily (BID) | Experimental | Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks Receives: Drug: INV-102 |
| INV-102 0.25% BID | Experimental | Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks Receives: Drug: INV-102 |
| INV-102 0.7% BID | Experimental | Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks Receives: Drug: INV-102 |
| INV-102 0.7% Three times daily (TID) | Experimental | Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks Receives: Drug: INV-102 |
| INV-102 TBD% BID | Experimental | Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4 Receives: Drug: INV-102 |
| Vehicle | Placebo comparator | Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event
The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens.
Measured: From first dose through study completion (Day 22)
Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)
The primary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Score in the study eye from the DED symptom VAS. The dry eye disease symptom visual analog scale consisted of various DED symptom parameters and was completed by subjects for each eye individually. Subjects were asked to rate their discomfort from 0 (no discomfort) to 100 (maximal discomfort) for each of the DED symptoms by placing a single vertical mark on a horizontal line based on the extent of their symptoms.
Measured: Day 15
Secondary outcomes (1)
Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score
The secondary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Composite Score in the study eye. The eye dryness composite score (points) combines the change from Baseline in eye dryness score from the DED symptom VAS and the change from Baseline in corneal fluorescein staining score. VAS eye dryness scores were rated by subjects on a scale of 0 (no discomfort) to 100 (maximal discomfort). Corneal fluorescein staining assessments were performed using the National Eye Institute/Industry grading scale to score each of 5 corneal zones on a 0 (no ocular surface disease) to 3 (severe ocular surface disease) scale (with a total score of 0 to 15). The calculated eye dryness composite score can range from -100 points to 100 points (positive values indicate worsening of dry eye disease signs and symptoms; negative values indicate improvement).
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start30 Aug 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 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
- NCT05586152
- Sponsor's protocol ID
- INV-102-CS-001
- Other IDs
- 75A50120C00171
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2022
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1/2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Multiple Ascending Dose (Part 1) and Optional Dose Expansion (Part 2) Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate Symptomatic Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05586152
- Acronym / sponsor ID
- INV-102-CS-001
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye, Keratoconjunctivitis sicca
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Invirsa, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic 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
- 6
| Arm | Type | Receives |
|---|---|---|
| INV-102 0.1% Twice daily (BID) | Experimental | Drug: INV-102Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks |
| INV-102 0.25% BID | Experimental | Drug: INV-102Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks |
| INV-102 0.7% BID | Experimental | Drug: INV-102Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks |
| INV-102 0.7% Three times daily (TID) | Experimental | Drug: INV-102Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks |
| INV-102 TBD% BID | Experimental | Drug: INV-102Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4 |
| Vehicle | Placebo comparator | Drug: VehiclePart 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or female subject ≥18 years of age
- Presence of moderate DED in at least one eye
Key exclusion criteria (7 listed)
- Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior
- Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- External eye disease except primary DED
- Systemic disease associated with DED
- History or evidence of ocular infection within the previous 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 0.1% Twice daily (BID), INV-102 0.25% BID, INV-102 0.7% BID, INV-102 0.7% Three times daily (TID), INV-102 TBD% BID |
| VehicleVehicle Ophthalmic Solution | Drug | Vehicle |
Primary outcome
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event
Time frame: From first dose through study completion (Day 22)
The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens.
Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)
Time frame: Day 15
The primary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Score in the study eye from the DED symptom VAS. The dry eye disease symptom visual analog scale consisted of various DED symptom parameters and was completed by subjects for each eye individually. Subjects were asked to rate their discomfort from 0 (no discomfort) to 100 (maximal discomfort) for each of the DED symptoms by placing a single vertical mark on a horizontal line based on the extent of their symptoms.
1 secondary outcome
Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 1/2 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 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event (time frame: From first dose through study completion (Day 22)). 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 18 Sep 2026.