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Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALY688 0.1%
ALY688 0.4%
Vehicle
Sponsored by
Allysta Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to meet specific sign and symptom criteria
  • Signs of ophthalmic allergic, inflammatory or infectious 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

Sites / Locations

  • Allysta Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Vehicle

ALY688 0.1%

ALY688 0.4%

Arm Description

Vehicle Ophthalmic Solution

ALY688 0.1% Ophthalmic Solution

ALY688 0.4%Ophthalmic Solution

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events
Subjects reporting any treatment-emergent adverse events
Eye Dryness Score (7-Day Average)
Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Corneal Fluorescein Staining
Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse

Secondary Outcome Measures

Ocular Discomfort Score by Visual Analog Scale
Mean change from baseline in ocular discomfort score of 7-day average using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Symptom Assessment in Dry Eye (SAnDE) Score Assessment
Mean change from baseline in Symptom Assessment in Dry Eye global symptom score on a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse. Global symptom score is calculated as the square root of the frequency score time the severity score per visit
Conjunctival Lissamine Green Staining
Mean change from baseline in zonal conjunctival lissamine green staining in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
Conjunctival Hyperemia Grading
Mean change from baseline in zonal conjunctival hyperemia in study eye using a 0- to 4-unit clinical grading scale and standardized grading photos, with 0 being better and 4 being worse
Tear Film Break-up Time (TBUT)
Mean change from baseline in TBUT in study eye
Schirmer's Test
Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test

Full Information

First Posted
December 12, 2019
Last Updated
June 19, 2023
Sponsor
Allysta Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04201574
Brief Title
Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Official Title
A Phase 1/2a, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Exploratory Activity of Two Concentrations of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allysta Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease
Detailed Description
This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle Ophthalmic Solution
Arm Title
ALY688 0.1%
Arm Type
Experimental
Arm Description
ALY688 0.1% Ophthalmic Solution
Arm Title
ALY688 0.4%
Arm Type
Experimental
Arm Description
ALY688 0.4%Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
ALY688 0.1%
Other Intervention Name(s)
ALY688 Ophthalmic
Intervention Description
ALY688 0.1% Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
ALY688 0.4%
Other Intervention Name(s)
ALY688 Ophthalmic
Intervention Description
ALY688 0.4% Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
placebo
Intervention Description
Vehicle Ophthalmic Solution
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events
Description
Subjects reporting any treatment-emergent adverse events
Time Frame
8 weeks
Title
Eye Dryness Score (7-Day Average)
Description
Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Time Frame
8 weeks
Title
Corneal Fluorescein Staining
Description
Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Ocular Discomfort Score by Visual Analog Scale
Description
Mean change from baseline in ocular discomfort score of 7-day average using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Time Frame
8 weeks
Title
Symptom Assessment in Dry Eye (SAnDE) Score Assessment
Description
Mean change from baseline in Symptom Assessment in Dry Eye global symptom score on a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse. Global symptom score is calculated as the square root of the frequency score time the severity score per visit
Time Frame
8 weeks
Title
Conjunctival Lissamine Green Staining
Description
Mean change from baseline in zonal conjunctival lissamine green staining in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
Time Frame
8 weeks
Title
Conjunctival Hyperemia Grading
Description
Mean change from baseline in zonal conjunctival hyperemia in study eye using a 0- to 4-unit clinical grading scale and standardized grading photos, with 0 being better and 4 being worse
Time Frame
8 weeks
Title
Tear Film Break-up Time (TBUT)
Description
Mean change from baseline in TBUT in study eye
Time Frame
8 weeks
Title
Schirmer's Test
Description
Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dry eye disease for > 3 months meeting specific sign and symptom criteria Best correct visual acuity of +0.6 logMAR or better Willing to sign informed consent and attend study visits Willing to comply with contraception requirements Exclusion Criteria: Unable to meet specific sign and symptom criteria Signs of ophthalmic allergic, inflammatory or infectious 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Hsu, MD
Organizational Affiliation
Allysta Pharmaceutical
Official's Role
Study Director
Facility Information:
Facility Name
Allysta Pharmaceuticals
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98006
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

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