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

Invirsa

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: Vehicle; Drug: INV-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT06370039

INV-102-CS-003

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

109 participants in 2 patient groups, including a placebo group

INV-102

Experimental group

Description:

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)

Treatment:

Drug: INV-102

Vehicle

Placebo Comparator group

Description:

Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks)

Treatment:

Drug: Vehicle