Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye (NCT NCT05109702)

Last Updated: 2023-10-23

Results Overview

CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

260 participants

Primary outcome timeframe

Baseline, Day 57 (Week 8)

Results posted on

2023-10-23

Participant Flow

Participants who met all the eligibility criteria were enrolled at sites in the United States.

Participants entered the 14-day Placebo Run-in Period prior to randomization and during the 14-day period, assessments were conducted to ascertain eligibility to enter the study. Those who qualified were randomized to receive investigational product (0.25% tanfanercept ophthalmic solution or placebo) in a double-masked fashion for 8 weeks in the Treatment Period.

Participant milestones

Participant milestones
Measure	Placebo Run-in Participants self-administered placebo ocular drops. twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period.	0.25% Tanfanercept Ophthalmic Solution Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Placebo Run-in Period (14 Days) STARTED	260	0	0
Placebo Run-in Period (14 Days) COMPLETED	260	0	0
Placebo Run-in Period (14 Days) NOT COMPLETED	0	0	0
Treatment Period (8 Weeks) STARTED	0	130	130
Treatment Period (8 Weeks) COMPLETED	0	116	122
Treatment Period (8 Weeks) NOT COMPLETED	0	14	8

Reasons for withdrawal

Reasons for withdrawal
Measure	0.25% Tanfanercept Ophthalmic Solution Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Treatment Period (8 Weeks) Adverse Event	5	2
Treatment Period (8 Weeks) Protocol Violation	0	1
Treatment Period (8 Weeks) Withdrawal by Subject	5	3
Treatment Period (8 Weeks) Administrative reasons	1	1
Treatment Period (8 Weeks) Other than specified	3	1

Baseline Characteristics

A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.25% Tanfanercept Ophthalmic Solution n=130 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=130 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Total n=260 Participants Total of all reporting groups
Age, Continuous	62.4 years STANDARD_DEVIATION 13.31 • n=5 Participants	63.1 years STANDARD_DEVIATION 11.20 • n=7 Participants	62.7 years STANDARD_DEVIATION 12.28 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	90 Participants n=7 Participants	182 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=5 Participants	121 Participants n=7 Participants	239 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	103 Participants n=7 Participants	201 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 57 (Week 8)

Population: ITT population with available data was analyzed.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=130 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=130 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 Baseline	2.40 score on a scale Standard Deviation 0.497	2.37 score on a scale Standard Deviation 0.477
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 Change at Week 8	-0.82 score on a scale Standard Deviation 0.812	-0.79 score on a scale Standard Deviation 0.806

PRIMARY outcome

Timeframe: Baseline, Day 57 (Week 8)

Population: ITT population with available data were analyzed.

Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=130 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=130 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 Baseline	66.1 percentage of dryness Standard Deviation 22.95	60.8 percentage of dryness Standard Deviation 25.57
Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 Change at Week 8	-16.19 percentage of dryness Standard Deviation 30.625	-19.79 percentage of dryness Standard Deviation 26.317

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region Change at Week 1	-0.43 score on a scale Standard Deviation 0.649	-0.59 score on a scale Standard Deviation 0.667
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region Change at Week 2	-0.45 score on a scale Standard Deviation 0.814	-0.61 score on a scale Standard Deviation 0.723
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region Change at Week 4	-0.57 score on a scale Standard Deviation 0.788	-0.64 score on a scale Standard Deviation 0.861
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region Change at Week 8	-0.82 score on a scale Standard Deviation 0.812	-0.79 score on a scale Standard Deviation 0.806

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region Change at Week 1	-0.21 score on a scale Standard Deviation 0.572	-0.20 score on a scale Standard Deviation 0.639
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region Change at Week 2	-0.22 score on a scale Standard Deviation 0.805	-0.21 score on a scale Standard Deviation 0.705
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region Change at Week 4	-0.25 score on a scale Standard Deviation 0.731	-0.25 score on a scale Standard Deviation 0.753
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region Change at Week 8	-0.37 score on a scale Standard Deviation 0.747	-0.33 score on a scale Standard Deviation 0.729

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region Change at Week 1	-0.14 score on a scale Standard Deviation 0.611	-0.13 score on a scale Standard Deviation 0.684
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region Change at Week 2	-0.10 score on a scale Standard Deviation 0.732	-0.24 score on a scale Standard Deviation 0.729
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region Change at Week 4	-0.12 score on a scale Standard Deviation 0.756	-0.15 score on a scale Standard Deviation 0.770
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region Change at Week 8	-0.33 score on a scale Standard Deviation 0.708	-0.27 score on a scale Standard Deviation 0.892

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region Change at Week 1	-0.16 score on a scale Standard Deviation 0.742	-0.13 score on a scale Standard Deviation 0.749
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region Change at Week 2	-0.14 score on a scale Standard Deviation 0.870	-0.19 score on a scale Standard Deviation 0.785
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region Change at Week 4	-0.17 score on a scale Standard Deviation 0.875	-0.27 score on a scale Standard Deviation 0.756
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region Change at Week 8	-0.20 score on a scale Standard Deviation 0.746	-0.40 score on a scale Standard Deviation 0.827

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region Change at Week 1	-0.12 score on a scale Standard Deviation 0.703	-0.16 score on a scale Standard Deviation 0.700
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region Change at Week 2	-0.17 score on a scale Standard Deviation 0.860	-0.23 score on a scale Standard Deviation 0.797
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region Change at Week 4	-0.19 score on a scale Standard Deviation 0.817	-0.27 score on a scale Standard Deviation 0.822
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region Change at Week 8	-0.19 score on a scale Standard Deviation 0.829	-0.33 score on a scale Standard Deviation 0.879

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed.

The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12, and lower score indicated improvement.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum Change at Week 1	-0.78 score on a scale Standard Deviation 1.370	-0.91 score on a scale Standard Deviation 1.585
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum Change at Week 2	-0.76 score on a scale Standard Deviation 1.929	-1.06 score on a scale Standard Deviation 1.750
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum Change at Week 4	-0.94 score on a scale Standard Deviation 1.877	-1.04 score on a scale Standard Deviation 1.976
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum Change at Week 8	-1.52 score on a scale Standard Deviation 1.904	-1.39 score on a scale Standard Deviation 2.049

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed.

The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for conjunctival regions was derived the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum Change at Week 1	-0.28 score on a scale Standard Deviation 1.219	-0.29 score on a scale Standard Deviation 1.184
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum Change at Week 2	-0.31 score on a scale Standard Deviation 1.582	-0.42 score on a scale Standard Deviation 1.371
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum Change at Week 4	-0.36 score on a scale Standard Deviation 1.463	-0.54 score on a scale Standard Deviation 1.352
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum Change at Week 8	-0.39 score on a scale Standard Deviation 1.427	-0.74 score on a scale Standard Deviation 1.510

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed.

The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, temporal, and nasal regions. Total score ranged between 0 to 20, and lower score indicated improvement.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining Change at Week 1	-1.07 score on a scale Standard Deviation 2.104	-1.20 score on a scale Standard Deviation 2.395
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining Change at Week 2	-1.07 score on a scale Standard Deviation 3.125	-1.48 score on a scale Standard Deviation 2.672
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining Change at Week 4	-1.30 score on a scale Standard Deviation 2.974	-1.58 score on a scale Standard Deviation 2.956
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining Change at Week 8	-1.92 score on a scale Standard Deviation 2.931	-2.12 score on a scale Standard Deviation 3.234

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region Change at Week 1	0.01 score on a scale Standard Deviation 0.663	-0.16 score on a scale Standard Deviation 0.672
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region Change at Week 2	-0.13 score on a scale Standard Deviation 0.549	-0.25 score on a scale Standard Deviation 0.579
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region Change at Week 4	-0.24 score on a scale Standard Deviation 0.616	-0.30 score on a scale Standard Deviation 0.624
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region Change at Week 8	-0.29 score on a scale Standard Deviation 0.602	-0.30 score on a scale Standard Deviation 0.628

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region Change at Week 1	-0.11 score on a scale Standard Deviation 0.800	-0.12 score on a scale Standard Deviation 0.523
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region Change at Week 2	-0.20 score on a scale Standard Deviation 0.721	-0.17 score on a scale Standard Deviation 0.576
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region Change at Week 4	-0.25 score on a scale Standard Deviation 0.674	-0.22 score on a scale Standard Deviation 0.549
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region Change at Week 8	-0.18 score on a scale Standard Deviation 0.592	-0.19 score on a scale Standard Deviation 0.656

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region Change at Week 1	-0.07 score on a scale Standard Deviation 0.789	-0.14 score on a scale Standard Deviation 0.797
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region Change at Week 2	-0.06 score on a scale Standard Deviation 0.766	-0.33 score on a scale Standard Deviation 0.741
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region Change at Week 4	-0.25 score on a scale Standard Deviation 0.606	-0.27 score on a scale Standard Deviation 0.802
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region Change at Week 8	-0.23 score on a scale Standard Deviation 0.700	-0.33 score on a scale Standard Deviation 0.889

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region Change at Week 1	-0.02 score on a scale Standard Deviation 0.875	-0.18 score on a scale Standard Deviation 0.809
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region Change at Week 2	-0.17 score on a scale Standard Deviation 0.924	-0.25 score on a scale Standard Deviation 0.817
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region Change at Week 4	-0.23 score on a scale Standard Deviation 0.822	-0.31 score on a scale Standard Deviation 0.790
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region Change at Week 8	-0.15 score on a scale Standard Deviation 0.817	-0.17 score on a scale Standard Deviation 0.896

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region Change at Week 1	-0.13 score on a scale Standard Deviation 0.735	-0.10 score on a scale Standard Deviation 0.781
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region Change at Week 2	-0.25 score on a scale Standard Deviation 0.962	-0.35 score on a scale Standard Deviation 0.699
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region Change at Week 4	-0.19 score on a scale Standard Deviation 0.775	-0.24 score on a scale Standard Deviation 0.896
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region Change at Week 8	-0.11 score on a scale Standard Deviation 0.926	-0.31 score on a scale Standard Deviation 1.044

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12,and lower score indicated improvement.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum Change at Week 1	-0.17 score on a scale Standard Deviation 1.622	-0.42 score on a scale Standard Deviation 1.526
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum Change at Week 2	-0.39 score on a scale Standard Deviation 1.395	-0.75 score on a scale Standard Deviation 1.445
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum Change at Week 4	-0.74 score on a scale Standard Deviation 1.334	-0.79 score on a scale Standard Deviation 1.516
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum Change at Week 8	-0.69 score on a scale Standard Deviation 1.344	-0.82 score on a scale Standard Deviation 1.691

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for conjunctival regions was derived as the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum Change at Week 1	-0.14 score on a scale Standard Deviation 1.397	-0.29 score on a scale Standard Deviation 1.261
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum Change at Week 2	-0.42 score on a scale Standard Deviation 1.600	-0.60 score on a scale Standard Deviation 1.307
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum Change at Week 4	-0.42 score on a scale Standard Deviation 1.348	-0.54 score on a scale Standard Deviation 1.488
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum Change at Week 8	-0.26 score on a scale Standard Deviation 1.537	-0.48 score on a scale Standard Deviation 1.717

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, nasal, and temporal regions. Total score ranged between 0 to 20, and lower score indicated improvement.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining Change at Week 1	-0.32 score on a scale Standard Deviation 2.634	-0.71 score on a scale Standard Deviation 2.252
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining Change at Week 2	-0.81 score on a scale Standard Deviation 2.618	-1.35 score on a scale Standard Deviation 2.277
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining Change at Week 4	-1.16 score on a scale Standard Deviation 2.262	-1.33 score on a scale Standard Deviation 2.507
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining Change at Week 8	-0.95 score on a scale Standard Deviation 2.364	-1.29 score on a scale Standard Deviation 2.912

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

It was evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 Change at Week 1	-0.10 score on a scale Standard Deviation 0.450	-0.08 score on a scale Standard Deviation 0.519
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 Change at Week 2	-0.14 score on a scale Standard Deviation 0.435	-0.19 score on a scale Standard Deviation 0.456
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 Change at Week 4	-0.13 score on a scale Standard Deviation 0.577	-0.22 score on a scale Standard Deviation 0.534
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 Change at Week 8	-0.09 score on a scale Standard Deviation 0.648	-0.32 score on a scale Standard Deviation 0.544

SECONDARY outcome

Timeframe: Baseline; Weeks 2, 4, and 8

Population: ITT population with available data was analyzed

The Schirmer test strip was placed in the lower temporal lid margin of each eye. Participants were instructed to close their eyes and after 5 minutes had elapsed, the length of moistened area of schirmer strip was recorded (millimeter \[mm\]) for each eye.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=124 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 Change at Week 2	0.69 mm Standard Deviation 5.155	0.31 mm Standard Deviation 4.361
Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 Change at Week 4	1.24 mm Standard Deviation 5.858	0.56 mm Standard Deviation 4.972
Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 Change at Week 8	2.45 mm Standard Deviation 5.913	0.51 mm Standard Deviation 4.257

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it took to form micelles from the time that the eye is opened was noted.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 Change at Week 1	0.45 seconds Standard Deviation 1.643	0.55 seconds Standard Deviation 1.513
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 Change at Week 2	0.17 seconds Standard Deviation 1.168	0.42 seconds Standard Deviation 1.171
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 Change at Week 4	0.16 seconds Standard Deviation 1.064	0.57 seconds Standard Deviation 1.600
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 Change at Week 8	0.52 seconds Standard Deviation 1.548	0.48 seconds Standard Deviation 1.226

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Participants rated ocular symptom of burning/stinging by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging Change at Week 1	-7.49 percentage of burining/stinging Standard Deviation 27.712	-5.43 percentage of burining/stinging Standard Deviation 21.630
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging Change at Week 2	-8.74 percentage of burining/stinging Standard Deviation 26.961	-9.66 percentage of burining/stinging Standard Deviation 23.478
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging Change at Week 4	-11.84 percentage of burining/stinging Standard Deviation 29.437	-9.04 percentage of burining/stinging Standard Deviation 22.261
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging Change at Week 8	-12.17 percentage of burining/stinging Standard Deviation 28.441	-11.82 percentage of burining/stinging Standard Deviation 22.174

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Participants rated ocular symptom of foreign body sensation by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation Change at Week 1	-4.63 percentage of foreign body sensation Standard Deviation 23.060	-4.06 percentage of foreign body sensation Standard Deviation 23.349
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation Change at Week 2	-7.93 percentage of foreign body sensation Standard Deviation 23.489	-8.26 percentage of foreign body sensation Standard Deviation 22.783
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation Change at Week 4	-7.83 percentage of foreign body sensation Standard Deviation 25.806	-6.90 percentage of foreign body sensation Standard Deviation 22.919
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation Change at Week 8	-7.81 percentage of foreign body sensation Standard Deviation 30.745	-11.58 percentage of foreign body sensation Standard Deviation 25.182

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Participants rated ocular symptom of itching by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching Change at Week 1	-6.49 percentage of itching Standard Deviation 21.885	-5.52 percentage of itching Standard Deviation 20.820
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching Change at Week 2	-8.39 percentage of itching Standard Deviation 23.746	-9.07 percentage of itching Standard Deviation 21.807
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching Change at Week 4	-10.31 percentage of itching Standard Deviation 23.372	-9.78 percentage of itching Standard Deviation 22.738
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching Change at Week 8	-11.12 percentage of itching Standard Deviation 27.650	-14.33 percentage of itching Standard Deviation 21.512

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Participants rated ocular symptom of blurred vision by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision Change at Week 1	-5.95 percentage of blurred vision Standard Deviation 20.483	-7.53 percentage of blurred vision Standard Deviation 18.674
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision Change at Week 2	-8.94 percentage of blurred vision Standard Deviation 21.564	-8.61 percentage of blurred vision Standard Deviation 22.511
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision Change at Week 4	-9.50 percentage of blurred vision Standard Deviation 25.051	-9.49 percentage of blurred vision Standard Deviation 22.681
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision Change at Week 8	-9.24 percentage of blurred vision Standard Deviation 26.069	-9.46 percentage of blurred vision Standard Deviation 23.783

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Participants rated ocular symptom of eye dryness by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness Change at Week 1	-6.98 percentage of eye dryness Standard Deviation 22.840	-9.23 percentage of eye dryness Standard Deviation 21.209
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness Change at Week 2	-10.34 percentage of eye dryness Standard Deviation 23.308	-12.52 percentage of eye dryness Standard Deviation 22.974
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness Change at Week 4	-13.64 percentage of eye dryness Standard Deviation 26.572	-13.12 percentage of eye dryness Standard Deviation 23.297
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness Change at Week 8	-16.19 percentage of eye dryness Standard Deviation 30.625	-19.79 percentage of eye dryness Standard Deviation 26.317

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Participants rated ocular symptom of photophobia by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia Change at Week 1	-6.57 percentage of photophobia Standard Deviation 22.155	-3.56 percentage of photophobia Standard Deviation 22.871
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia Change at Week 2	-7.17 percentage of photophobia Standard Deviation 22.689	-5.54 percentage of photophobia Standard Deviation 23.594
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia Change at Week 4	-8.20 percentage of photophobia Standard Deviation 28.014	-9.10 percentage of photophobia Standard Deviation 26.350
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia Change at Week 8	-10.71 percentage of photophobia Standard Deviation 30.328	-12.18 percentage of photophobia Standard Deviation 28.722

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

Participants rated ocular symptom of pain by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain Change at Week 1	-6.27 percentage of pain Standard Deviation 22.501	-5.63 percentage of pain Standard Deviation 18.611
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain Change at Week 2	-5.00 percentage of pain Standard Deviation 23.843	-7.25 percentage of pain Standard Deviation 19.041
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain Change at Week 4	-6.27 percentage of pain Standard Deviation 29.718	-8.27 percentage of pain Standard Deviation 20.666
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain Change at Week 8	-7.23 percentage of pain Standard Deviation 27.317	-9.83 percentage of pain Standard Deviation 22.370

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

OSDI was a simple 12-question survey that rated the severity of the participant's dry eye disease based on the symptoms. Each question response ranged from 0 to 4, where 0 = None of the Time, 1 = Some of the Time, 2 = Half of the Time, 3 = Most of the Time, and 4 = All of the Time. Total OSDI score = (Sum of all answered questions) \* 25/ (number of questions answered); which ranged from 0 to 100, with higher score representing greater disability.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 Change at Week 1	-3.13 score on a scale Standard Deviation 13.229	-5.65 score on a scale Standard Deviation 14.785
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 Change at Week 2	-4.85 score on a scale Standard Deviation 16.092	-6.23 score on a scale Standard Deviation 14.617
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 Change at Week 4	-4.54 score on a scale Standard Deviation 18.002	-8.16 score on a scale Standard Deviation 15.170
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 Change at Week 8	-6.74 score on a scale Standard Deviation 18.702	-9.99 score on a scale Standard Deviation 14.215

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data was analyzed

It was assessed by the Ora Calibra® ocular discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 Change at Week 1	-0.22 score on a scale Standard Deviation 1.177	-0.31 score on a scale Standard Deviation 1.084
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 Change at Week 2	-0.34 score on a scale Standard Deviation 1.172	-0.41 score on a scale Standard Deviation 1.060
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 Change at Week 4	-0.48 score on a scale Standard Deviation 1.294	-0.39 score on a scale Standard Deviation 1.110
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 Change at Week 8	-0.53 score on a scale Standard Deviation 1.261	-0.71 score on a scale Standard Deviation 1.083

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data will be analyzed

Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort Change at Week 1	-0.44 score on a scale Standard Deviation 1.304	-0.23 score on a scale Standard Deviation 1.409
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort Change at Week 2	-0.42 score on a scale Standard Deviation 1.277	-0.29 score on a scale Standard Deviation 1.338
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort Change at Week 4	-0.56 score on a scale Standard Deviation 1.477	-0.35 score on a scale Standard Deviation 1.238
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort Change at Week 8	-0.55 score on a scale Standard Deviation 1.511	-0.55 score on a scale Standard Deviation 1.304

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data will be analyzed

Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort Change at Week 1	-0.34 score on a scale Standard Deviation 1.048	-0.34 score on a scale Standard Deviation 1.234
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort Change at Week 2	-0.43 score on a scale Standard Deviation 1.266	-0.43 score on a scale Standard Deviation 1.268
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort Change at Week 4	-0.60 score on a scale Standard Deviation 1.334	-0.44 score on a scale Standard Deviation 1.314
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort Change at Week 8	-0.66 score on a scale Standard Deviation 1.446	-0.74 score on a scale Standard Deviation 1.262

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data will be analyzed

Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort Change at Week 1	-0.26 score on a scale Standard Deviation 1.231	-0.29 score on a scale Standard Deviation 1.278
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort Change at Week 2	-0.45 score on a scale Standard Deviation 1.478	-0.56 score on a scale Standard Deviation 1.293
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort Change at Week 4	-0.48 score on a scale Standard Deviation 1.421	-0.38 score on a scale Standard Deviation 1.214
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort Change at Week 8	-0.58 score on a scale Standard Deviation 1.441	-0.59 score on a scale Standard Deviation 1.302

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: ITT population with available data will be analyzed

Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=125 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort Change at Week 1	-0.30 score on a scale Standard Deviation 1.193	-0.31 score on a scale Standard Deviation 1.365
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort Change at Week 2	-0.34 score on a scale Standard Deviation 1.191	-0.52 score on a scale Standard Deviation 1.250
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort Change at Week 4	-0.50 score on a scale Standard Deviation 1.362	-0.50 score on a scale Standard Deviation 1.370
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort Change at Week 8	-0.50 score on a scale Standard Deviation 1.371	-0.61 score on a scale Standard Deviation 1.254

SECONDARY outcome

Timeframe: Week 1

Population: ITT population with available data was analyzed

Ora Calibra® drop comfort scale ranged from 0 to 10. A score of 0 indicated comfortable and 10 indicated uncomfortable. Lower score indicated better comfort level. Immediately Upon Instillation, 1 Minute Post Instillation and 2 Minutes Post Instillation at Week 1

Outcome measures

Outcome measures
Measure	0.25% Tanfanercept Ophthalmic Solution n=124 Participants Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=126 Participants Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Ora Calibra® Drop Comfort Assessment at Week 1 Immediately Upon Instillation at Week 1	2.55 score on a scale Standard Deviation 2.673	2.72 score on a scale Standard Deviation 2.532
Ora Calibra® Drop Comfort Assessment at Week 1 1 Minute Post Instillation at Week 1	1.95 score on a scale Standard Deviation 2.063	2.21 score on a scale Standard Deviation 2.174
Ora Calibra® Drop Comfort Assessment at Week 1 2 Minutes Post Instillation at Week 1	1.56 score on a scale Standard Deviation 1.884	1.79 score on a scale Standard Deviation 2.058

Adverse Events

Placebo Run-in

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

0.25% Tanfanercept Ophthalmic Solution

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Run-in n=260 participants at risk Participants self-administered placebo ocular drops BID in both eyes for 14 days in the Placebo Run-in Period.	0.25% Tanfanercept Ophthalmic Solution n=130 participants at risk Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.	Placebo n=130 participants at risk Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Nervous system disorders Neuromyopathy	0.00% 0/260 • Placebo Run-in arm: From enrollment up to Day 14 of Placebo Run-in Period 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm: From first dose up to Week 8 of Treatment Period Placebo Run-in arm: All the enrolled participants were included. 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm: Safety population included all randomized participants who received at least one dose of the investigational product. Placebo Run-in arm reports all AEs; 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm reports TEAEs. Treatment emergent AEs (any event that occurred or worsened on or after the day the randomized study treatment was initiated) were reported.	0.00% 0/130 • Placebo Run-in arm: From enrollment up to Day 14 of Placebo Run-in Period 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm: From first dose up to Week 8 of Treatment Period Placebo Run-in arm: All the enrolled participants were included. 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm: Safety population included all randomized participants who received at least one dose of the investigational product. Placebo Run-in arm reports all AEs; 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm reports TEAEs. Treatment emergent AEs (any event that occurred or worsened on or after the day the randomized study treatment was initiated) were reported.	0.77% 1/130 • Placebo Run-in arm: From enrollment up to Day 14 of Placebo Run-in Period 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm: From first dose up to Week 8 of Treatment Period Placebo Run-in arm: All the enrolled participants were included. 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm: Safety population included all randomized participants who received at least one dose of the investigational product. Placebo Run-in arm reports all AEs; 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm reports TEAEs. Treatment emergent AEs (any event that occurred or worsened on or after the day the randomized study treatment was initiated) were reported.

Other adverse events

Additional Information

Project Manager

Hanall Biopharma

Phone: 82-222041763

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place