NCT03925727

Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Completed Phase 3 Results posted Last updated 5 April 2023

What this trial tests

Phase 3 trial testing Tavilermide ophthalmic solution in Keratoconjunctivitis Sicca in 623 participants. Completed in 11 June 2020.

Timeline

28 March 2019

Primary endpoint
11 June 2020

11 June 2020

Quick facts

Lead sponsor	Mimetogen Pharmaceuticals USA, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	623
Start date	28 March 2019
Primary completion	11 June 2020
Estimated completion	11 June 2020
Sites	22 locations across United States

Drugs / interventions tested

• Tavilermide ophthalmic solution — full drug profile →
• Placebo

Conditions studied

• Keratoconjunctivitis Sicca — all drugs for Keratoconjunctivitis Sicca →
• Dry Eye — all drugs for Dry Eye →

Sponsor

Mimetogen Pharmaceuticals USA, Inc. — full company profile →

Who can join

Adults 18 to 99, any sex, with Keratoconjunctivitis Sicca or Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Eye Dryness Score as Measured by the VAS Primary · Baseline to Day 85 in 5% Tavilermide versus Placebo

The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.

Group	Value	95% CI
Tavilermide 5%	-15.1	± 1.64
Tavilermide 1%	-20.6	± 2.66
Placebo	-16.5	± 1.67

Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale Primary · Baseline to Day 85 in 5% Tavilermide versus Placebo

The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior) . Grade 0 was specified when no staining is present. The maximum score was 15. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.

Group	Value	95% CI
Tavilermide 5%	-2.6	± 0.17
Tavilermide 1%	-2.3	± 0.28
Placebo	-2.1	± 0.17

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tavilermide 5%

Serious: 2/261 (1%)

Deaths: 1/261

Tavilermide 1%

Serious: 0/99 (0%)

Deaths: 0/99

Placebo

Serious: 3/255 (1%)

Deaths: 0/255

Serious adverse events (5 terms)

Reaction	System	Tavilermide 5%	Tavilermide 1%	Placebo
Cerebrovascular accident	Nervous system disorders	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—
Osteomyelitis	Infections and infestations	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Knee arthroplasty	Surgical and medical procedures	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Tavilermide 5%	Tavilermide 1%	Placebo
Instillation site pain	General disorders	—	—	—

Most-reported serious reactions: Cerebrovascular accident, Lymphadenopathy, Osteomyelitis, Breast cancer, Knee arthroplasty.

Data from ClinicalTrials.gov NCT03925727 adverse events section.

Sponsor's own description

The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A, B, C's of Trk Receptors and Their Ligands in Ocular Repair.
   Gupta A, Galletti JG, Yu Z, Burgess K, et al · · 2022 · cited 9× · PMID 36430547 · DOI 10.3390/ijms232214069