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Completed

NCT Number: NCT04201574

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

Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Allysta Pharmaceuticals

Bellevue, Washington, 98006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALY688 0.1%

Drug

ALY688 0.1% Ophthalmic Solution

Other names: ALY688 Ophthalmic

ALY688 0.4%

Drug

ALY688 0.4% Ophthalmic Solution

Other names: ALY688 Ophthalmic

Vehicle

Drug

Vehicle Ophthalmic Solution

Other names: placebo

Primary outcomes

  1. Number of Subjects With Adverse Events

    Time frame: 8 weeks

    Subjects reporting any treatment-emergent adverse events

  2. Eye Dryness Score (7-Day Average)

    Time frame: 8 weeks

    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

  3. Corneal Fluorescein Staining

    Time frame: 8 weeks

    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 outcomes

  1. Ocular Discomfort Score by Visual Analog Scale

    Time frame: 8 weeks

    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

  2. Symptom Assessment in Dry Eye (SAnDE) Score Assessment

    Time frame: 8 weeks

    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

  3. Conjunctival Lissamine Green Staining

    Time frame: 8 weeks

    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

  4. Conjunctival Hyperemia Grading

    Time frame: 8 weeks

    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

  5. Tear Film Break-up Time (TBUT)

    Time frame: 8 weeks

    Mean change from baseline in TBUT in study eye

  6. Schirmer's Test

    Time frame: 8 weeks

    Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test

Sponsors and collaborators

Lead sponsor

Allysta Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2019
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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