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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06370039
• Other study ID #: INV-102-CS-003
• Status: Recruiting
• Phase: Phase 2
• Start date: March 27, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Invirsa, Inc.
• Contact: Invirsa Call Center
• Phone: 614-334-1765
• Email: info[@]invirsa.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• INV-102
INV-102 Ophthalmic Solution
• Vehicle
Vehicle Ophthalmic Solution

Locations

Country	Name	City	State
United States	iuvo BioScience	Rush	New York

Sponsors (1)

Lead Sponsor	Collaborator
Invirsa, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Day 29
Secondary	Percentage of eyes with complete clearing of central corneal fluorescein staining		Baseline to Day 29