Safety and Efficacy of TOP1630 for Dry Eye Syndrome

Ora, Inc.

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: Placebo to TOP1630 Ophthalmic Solution; Drug: TOP1630 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03088605

TOP1630-TV-04

Details and patient eligibility

About

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.

Full description

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

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

TOP1630 Ophthalmic Solution

Treatment:

Drug: TOP1630 Ophthalmic Solution

Placebo

Placebo Comparator group

Description:

Placebo (Vehicle) Ophthalmic Solution

Treatment:

Drug: Placebo to TOP1630 Ophthalmic Solution