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Completed

NCT Number: NCT04899518

ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Allysta Pharmaceuticals

Bellevue, Washington, 98004, United States

About this study

Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

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 corrected 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 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

Treatment and study plan

ALY688 Ophthalmic Solution

Drug

Ophthalmic Solution

Primary outcomes

  1. Corneal fluorescein staining

    Time frame: 8 weeks

    Difference between ALY688 Ophthalmic Solution 0.4% and vehicle

Sponsors and collaborators

Lead sponsor

Allysta Pharmaceutical

Industry

Registry information

Official study title

A Phase 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)

Acronym: OASIS-1

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 24, 2021
Registry last updated
Mar 16, 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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