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ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04899518
Recruitment Status : Completed
First Posted : May 24, 2021
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
Allysta Pharmaceutical

Study Description
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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

Condition or disease Intervention/treatment Phase
Dry Eye Drug: ALY688 Ophthalmic Solution Phase 2 Phase 3

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 922 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : May 19, 2021
Actual Primary Completion Date : March 14, 2023
Actual Study Completion Date : March 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Vehicle Ophthalmic Solution Drug: ALY688 Ophthalmic Solution
Ophthalmic Solution
Experimental: ALY688 Ophthalmic Solution Concentration 1 Drug: ALY688 Ophthalmic Solution
Ophthalmic Solution
Experimental: ALY688 Ophthalmic Solution Concentration 2 Drug: ALY688 Ophthalmic Solution
Ophthalmic Solution


Outcome Measures
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Primary Outcome Measures :
  1. Corneal fluorescein staining [ Time Frame: 8 weeks ]
    Difference between ALY688 Ophthalmic Solution 0.4% and vehicle


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899518


Locations
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United States, Washington
Allysta Pharmaceuticals
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Allysta Pharmaceutical
More Information
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Responsible Party: Allysta Pharmaceutical
ClinicalTrials.gov Identifier: NCT04899518    
Other Study ID Numbers: ALY688-301
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions