Clinical Trials Logo
  1. Home
  2. Dry Eye Disease
  3. NCT06370039
  4. Details
NCT06370039 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT03216096 - Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease Phase 1
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT04656197 - The Ocular Microbiome in Patients With Dry Eye Disease
Completed NCT05031806 - Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease Phase 1
Completed NCT03688802 - Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation Phase 2
Completed NCT05213156 - Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease Phase 4
Completed NCT04548427 - Study to Evaluate the Efficacy and Safety of CKD-352 Phase 3
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Completed NCT02254265 - Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca Phase 2/Phase 3
Completed NCT00395759 - The Visual Effect of an Investigational Artificial Tear in the Tear Layer. N/A
Completed NCT00680108 - A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution Phase 2
Recruiting NCT06064071 - Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD N/A
Completed NCT04139122 - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease Phase 1/Phase 2
Not yet recruiting NCT06375343 - Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® Phase 1
Completed NCT01468168 - A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients Phase 2
Completed NCT01014078 - A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease Phase 4
Completed NCT00799682 - Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z® Phase 4
Completed NCT05082974 - Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK) Phase 3
Recruiting NCT06146881 - Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia Phase 2
Completed NCT03292809 - CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) Phase 2/Phase 3