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

Allysta Pharmaceutical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye

Treatments: Drug: ALY688 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04899518

ALY688-301

Details and patient eligibility

About

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

Full 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

Enrollment: 922 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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922 participants in 3 patient groups, including a placebo group

Vehicle Ophthalmic Solution

Placebo Comparator group

Treatment:

Drug: ALY688 Ophthalmic Solution

ALY688 Ophthalmic Solution Concentration 1

Experimental group

Treatment:

Drug: ALY688 Ophthalmic Solution

ALY688 Ophthalmic Solution Concentration 2

Experimental group

Treatment:

Drug: ALY688 Ophthalmic Solution