Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Allysta Pharmaceutical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: Vehicle; Drug: ALY688 0.4%; Drug: ALY688 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04201574

ALY688-201

Details and patient eligibility

About

Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease

Full description

This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.

Enrollment: 138 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 correct 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 infectious 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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138 participants in 3 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Vehicle Ophthalmic Solution

Treatment:

Drug: Vehicle

ALY688 0.1%

Experimental group

Description:

ALY688 0.1% Ophthalmic Solution

Treatment:

Drug: ALY688 0.1%

ALY688 0.4%

Experimental group

Description:

ALY688 0.4%Ophthalmic Solution

Treatment:

Drug: ALY688 0.4%