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INV-102 0.1% BID for Dry Eye Syndrome

Phase 1 & 2
Waitlist Available
Research Sponsored by Invirsa, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (day 22)
Awards & highlights

Study Summary

This trial tests INV-102 eyedrops for safety & effectiveness in treating moderate dry eye disease over 2 weeks. Part 1 assesses safety & Part 2 assesses efficacy.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (day 22)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (day 22) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Characterize the safety profile of INV-102
Part 2: Evaluate the efficacy of INV-102 in an expanded cohort
Secondary outcome measures
Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: INV-102 TBD% BIDExperimental Treatment1 Intervention
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
Group II: INV-102 0.7% TIDExperimental Treatment1 Intervention
Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks
Group III: INV-102 0.7% BIDExperimental Treatment1 Intervention
Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks
Group IV: INV-102 0.25% BIDExperimental Treatment1 Intervention
Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks
Group V: INV-102 0.1% BIDExperimental Treatment1 Intervention
Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks
Group VI: VehiclePlacebo Group1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INV-102
2022
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Invirsa, Inc.Lead Sponsor
1 Previous Clinical Trials
102 Total Patients Enrolled
Biomedical Advanced Research and Development AuthorityFED
76 Previous Clinical Trials
908,397 Total Patients Enrolled
Robert Shalwitz, MDStudy ChairInvirsa, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently included in this clinical trial's patient cohort?

"Affirmative. According to clinicaltrials.gov, this medical trail is open for participants as of August 30th 2022 and was recently updated on October 14th 2022. 72 patients are being sought out by one healthcare facility for the study's duration."

Answered by AI

Is there an opportunity to enroll in this experiment at the present time?

"Data from clinicaltrials.gov indicates that this research study is actively seeking participants, with the trial having been posted on August 30th 2022 and updated as of October 14th 2022."

Answered by AI
~35 spots leftby Feb 2025