Trial Outcomes & Findings for Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease (NCT NCT05586152)

Last Updated: 2026-04-27

Results Overview

The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

84 participants

Primary outcome timeframe

From first dose through study completion (Day 22)

Results posted on

2026-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1 0.1% INV-102 BID Part 1, Cohort 1: 0.1% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.25% INV-102 BID Part 1, Cohort 2: 0.25% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.7% INV-102 BID Part 1, Cohort 3: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.7% INV-102 TID Part 1, Cohort 4: 0.7% INV-102 ophthalmic solution administered three times daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 Vehicle Part 1 (Cohorts 1-4): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks Vehicle: Vehicle Ophthalmic Solution	Part 2 0.7% INV-102 BID Part 2, Cohort 5: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks (dose was based on the results from Part 1, Cohorts 1 to 4) INV-102: INV-102 Ophthalmic Solution	Part 2 Vehicle Part 2 (Cohort 5): Vehicle ophthalmic solution administered twice daily for 2 weeks Vehicle: Vehicle Ophthalmic Solution
Overall Study STARTED	6	6	6	6	12	32	16
Overall Study COMPLETED	6	6	6	6	12	32	15
Overall Study NOT COMPLETED	0	0	0	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 0.1% INV-102 BID n=6 Participants Part 1, Cohort 1: 0.1% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.25% INV-102 BID n=6 Participants Part 1, Cohort 2: 0.25% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.7% INV-102 BID n=6 Participants Part 1, Cohort 3: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.7% INV-102 TID n=6 Participants Part 1, Cohort 4: 0.7% INV-102 ophthalmic solution administered three times daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 Vehicle n=12 Participants Part 1 (Cohorts 1-4): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks Vehicle: Vehicle Ophthalmic Solution	Part 2 0.7% INV-102 BID n=32 Participants Part 2, Cohort 5: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks (dose was based on the results from Part 1, Cohorts 1 to 4) INV-102: INV-102 Ophthalmic Solution	Part 2 Vehicle n=16 Participants Part 2 (Cohort 5): Vehicle ophthalmic solution administered twice daily for 2 weeks Vehicle: Vehicle Ophthalmic Solution	Total n=84 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 6.52 • n=226 Participants	67.8 years STANDARD_DEVIATION 9.62 • n=240 Participants	61.3 years STANDARD_DEVIATION 12.53 • n=236 Participants	55.8 years STANDARD_DEVIATION 14.62 • n=702 Participants	67.4 years STANDARD_DEVIATION 13.87 • n=211 Participants	60.2 years STANDARD_DEVIATION 11.91 • n=76 Participants	65.0 years STANDARD_DEVIATION 11.68 • n=401 Participants	62.4 years STANDARD_DEVIATION 12.11 • n=6 Participants
Sex: Female, Male Female	5 Participants n=226 Participants	4 Participants n=240 Participants	3 Participants n=236 Participants	5 Participants n=702 Participants	8 Participants n=211 Participants	19 Participants n=76 Participants	10 Participants n=401 Participants	54 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=226 Participants	2 Participants n=240 Participants	3 Participants n=236 Participants	1 Participants n=702 Participants	4 Participants n=211 Participants	13 Participants n=76 Participants	6 Participants n=401 Participants	30 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	0 Participants n=702 Participants	0 Participants n=211 Participants	1 Participants n=76 Participants	1 Participants n=401 Participants	2 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=226 Participants	6 Participants n=240 Participants	6 Participants n=236 Participants	6 Participants n=702 Participants	12 Participants n=211 Participants	31 Participants n=76 Participants	15 Participants n=401 Participants	82 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	0 Participants n=702 Participants	0 Participants n=211 Participants	0 Participants n=76 Participants	0 Participants n=401 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	0 Participants n=702 Participants	0 Participants n=211 Participants	1 Participants n=76 Participants	0 Participants n=401 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=226 Participants	0 Participants n=240 Participants	2 Participants n=236 Participants	1 Participants n=702 Participants	0 Participants n=211 Participants	1 Participants n=76 Participants	2 Participants n=401 Participants	6 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	0 Participants n=702 Participants	0 Participants n=211 Participants	0 Participants n=76 Participants	0 Participants n=401 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	2 Participants n=226 Participants	2 Participants n=240 Participants	1 Participants n=236 Participants	2 Participants n=702 Participants	3 Participants n=211 Participants	9 Participants n=76 Participants	1 Participants n=401 Participants	20 Participants n=6 Participants
Race (NIH/OMB) White	4 Participants n=226 Participants	4 Participants n=240 Participants	3 Participants n=236 Participants	3 Participants n=702 Participants	9 Participants n=211 Participants	21 Participants n=76 Participants	13 Participants n=401 Participants	57 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	0 Participants n=702 Participants	0 Participants n=211 Participants	0 Participants n=76 Participants	0 Participants n=401 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	0 Participants n=702 Participants	0 Participants n=211 Participants	0 Participants n=76 Participants	0 Participants n=401 Participants	0 Participants n=6 Participants
Region of Enrollment United States	6 participants n=226 Participants	6 participants n=240 Participants	6 participants n=236 Participants	6 participants n=702 Participants	12 participants n=211 Participants	32 participants n=76 Participants	16 participants n=401 Participants	84 participants n=6 Participants

PRIMARY outcome

Timeframe: From first dose through study completion (Day 22)

Population: Part 1 only. Safety population (all randomized subjects who received at least 1 drop of study drug.)

The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens.

Outcome measures

Outcome measures
Measure	Part 1 0.1% INV-102 BID n=6 Participants Part 1, Cohort 1: 0.1% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.25% INV-102 BID n=6 Participants Part 1, Cohort 2: 0.25% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.7% INV-102 BID n=6 Participants Part 1, Cohort 3: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.7% INV-102 TID n=6 Participants Part 1, Cohort 4: 0.7% INV-102 ophthalmic solution administered three times daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 Vehicle n=12 Participants Part 1 (Cohorts 1-4): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks Vehicle: Vehicle Ophthalmic Solution
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Part 2 only (Part 1 primary endpoint was safety). Modified intent-to-treat (mITT) population (all randomized subjects who received at least 1 drop of study drug in the Study Eye and completed at least 1 post-dosing assessment in the Study Eye). Study Eye: eye with more severe corneal fluorescein staining (CFS). If both eyes had same CFS score, eye with the more severe eye dryness score from the DED symptom VAS. If both eyes had same eye dryness score, the right eye was the Study Eye.

The primary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Score in the study eye from the DED symptom VAS. The dry eye disease symptom visual analog scale consisted of various DED symptom parameters and was completed by subjects for each eye individually. Subjects were asked to rate their discomfort from 0 (no discomfort) to 100 (maximal discomfort) for each of the DED symptoms by placing a single vertical mark on a horizontal line based on the extent of their symptoms.

Outcome measures

Outcome measures
Measure	Part 1 0.1% INV-102 BID n=32 Participants Part 1, Cohort 1: 0.1% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.25% INV-102 BID n=15 Participants Part 1, Cohort 2: 0.25% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.7% INV-102 BID Part 1, Cohort 3: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 0.7% INV-102 TID Part 1, Cohort 4: 0.7% INV-102 ophthalmic solution administered three times daily for 2 weeks INV-102: INV-102 Ophthalmic Solution	Part 1 Vehicle Part 1 (Cohorts 1-4): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks Vehicle: Vehicle Ophthalmic Solution
Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)	-15.50 score on a scale Standard Deviation 28.488	-21.20 score on a scale Standard Deviation 22.056	—	—	—

SECONDARY outcome

Timeframe: Day 15

The secondary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Composite Score in the study eye. The eye dryness composite score (points) combines the change from Baseline in eye dryness score from the DED symptom VAS and the change from Baseline in corneal fluorescein staining score. VAS eye dryness scores were rated by subjects on a scale of 0 (no discomfort) to 100 (maximal discomfort). Corneal fluorescein staining assessments were performed using the National Eye Institute/Industry grading scale to score each of 5 corneal zones on a 0 (no ocular surface disease) to 3 (severe ocular surface disease) scale (with a total score of 0 to 15). The calculated eye dryness composite score can range from -100 points to 100 points (positive values indicate worsening of dry eye disease signs and symptoms; negative values indicate improvement).