Safety and Efficacy of TOP1630 for Dry Eye Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2017-06-15

Brief Summary

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In subjects with Dry Eye Syndrome:

The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.

The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

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Detailed Description

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This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome.

Eligible subjects will be randomized double masked to either TOP1630 or placebo.

Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.

Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy

Conditions

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Dry Eye Syndrome

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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Active

TOP1630 Ophthalmic Solution

Group Type EXPERIMENTAL

TOP1630 Ophthalmic Solution

Intervention Type DRUG

Bilateral ocular drug administration

Placebo

Placebo (Vehicle) Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Placebo to TOP1630 Ophthalmic Solution

Intervention Type DRUG

Bilateral ocular drug administration

Interventions

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TOP1630 Ophthalmic Solution

Bilateral ocular drug administration

Intervention Type DRUG

Placebo to TOP1630 Ophthalmic Solution

Bilateral ocular drug administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye;
* Have a history of use of eye drops for dry eye symptoms;

Additionally for Part 2

Symptoms of dry eye syndrome including:

* Ocular discomfort
* Conjunctival redness
* Tear film break up time
* Schirmer test score

Signs of dry eye syndrome including:

Conjunctival staining score

Exclusion Criteria

* Have any clinically significant slit lamp findings at entry visit ;
* Be diagnosed with an ongoing ocular infection;
* Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI;
* Have any planned ocular and/or lid surgeries over the study period;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
* Have a known allergy and/or sensitivity to the test article or its components;
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No