ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04899518

Acronym

OASIS-1

Enrollment

922

Registered

2021-05-24

Start date

2021-05-19

Completion date

2023-03-14

Last updated

2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

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

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

Interventions

DRUGALY688 Ophthalmic Solution

Ophthalmic Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Corneal fluorescein staining	8 weeks	Difference between ALY688 Ophthalmic Solution 0.4% and vehicle

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026