CompletedPhase 2

Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease

United States109 participantsStarted 2024-03-27

Plain-language 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.

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Subjects ≥18 and \<75 years of age * Presence of moderate to severe dry eye disease (DED) in at least one eye Key Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale

Timeframe: Baseline to Day 29

Trial details

NCT IDNCT06370039

SponsorInvirsa, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-03

View on ClinicalTrials.gov More Dry Eye Disease trials

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.