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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2020-09-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vehicle

Vehicle Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle Ophthalmic Solution

ALY688 0.1%

ALY688 0.1% Ophthalmic Solution

Group Type EXPERIMENTAL

ALY688 0.1%

Intervention Type DRUG

ALY688 0.1% Ophthalmic Solution

ALY688 0.4%

ALY688 0.4%Ophthalmic Solution

Group Type EXPERIMENTAL

ALY688 0.4%

Intervention Type DRUG

ALY688 0.4% Ophthalmic Solution

Interventions

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ALY688 0.1%

ALY688 0.1% Ophthalmic Solution

Intervention Type DRUG

ALY688 0.4%

ALY688 0.4% Ophthalmic Solution

Intervention Type DRUG

Vehicle

Vehicle Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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ALY688 Ophthalmic ALY688 Ophthalmic placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No