NCT04899518

Brief Summary

Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
922

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

May 19, 2021

Last Update Submit

March 14, 2023

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Corneal fluorescein staining

    Difference between ALY688 Ophthalmic Solution 0.4% and vehicle

    8 weeks

Study Arms (3)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR
Drug: ALY688 Ophthalmic Solution

ALY688 Ophthalmic Solution Concentration 1

EXPERIMENTAL
Drug: ALY688 Ophthalmic Solution

ALY688 Ophthalmic Solution Concentration 2

EXPERIMENTAL
Drug: ALY688 Ophthalmic Solution

Interventions

ALY688 Ophthalmic SolutionDRUG

Ophthalmic Solution

ALY688 Ophthalmic Solution Concentration 1ALY688 Ophthalmic Solution Concentration 2Vehicle Ophthalmic Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry eye disease for \> 3 months meeting specific sign and symptom criteria
  • Best corrected visual acuity of +0.6 logMAR or better
  • Willing to sign informed consent and attend study visits
  • Willing to comply with contraception requirements

You may not qualify if:

  • Unable to meet specific sign and symptom criteria
  • Signs of ophthalmic allergic, inflammatory or infection conditions
  • Use of contact lenses
  • Anatomic abnormalities preventing accurate study assessments
  • Use of medications that influence eye dryness
  • Recent ophthalmic surgery
  • Unwilling to suspend current treatments for dry eye disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allysta Pharmaceuticals

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

May 19, 2021

Primary Completion

March 14, 2023

Study Completion

March 14, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)