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Completed

NCT Number: NCT05238597

A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of 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 2

Primary location

Aramis Site 113, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent must be obtained prior to any study-related assessments
  • Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1
  • Willing and able to follow instructions and can be present for required study visits

Exclusion criteria

  • Women who are pregnant or breastfeeding
  • Use of topical ophthalmic medications, artificial tears, eye drops and gels in either eye
  • Use of contact lenses within 90 days prior to Visit 1 and throughout the study
  • Have had an ocular infection in either eye within 90 days prior to Visit 1

Treatment and study plan

A197 Ophthalmic Solution

Drug

A197 Ophthalmic Solution

A197 Vehicle Control

Drug

A197 Vehicle Control

Active Comparator

Drug

Active Comparator

Primary outcomes

  1. Change from baseline in total corneal fluorescein staining (CFS)

    Time frame: 12 Weeks

    Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20.

Secondary outcomes

  1. Change from baseline in eye dryness via the Visual Analogue Scale (VAS)

    Time frame: 12 Weeks

    Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms.

  2. Change from baseline in lissamine green conjunctival staining (LGCS)

    Time frame: 12 Weeks

    Lissamine green conjunctival staining (LGCS) is graded based on the NEI Scale. The NEI scale divides the conjunctiva in 6 regions with the score for each region ranging from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 6 regions ranging from 0-18.

  3. Change from baseline in bulbar conjunctival hyperemia (CCLRU)

    Time frame: 12 Weeks

    Bulbar conjunctival hyperemia is graded based on the Cornea and Contact Lens Research Unit (CCLRU) grading scale where 0 corresponds to none, 4 corresponds to severe.

Sponsors and collaborators

Lead sponsor

Aramis Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2022
Registry last updated
May 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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