Clinical trial NCT03088605: Safety and Efficacy of TOP1630 for Dry Eye Syndrome
Official title: A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Topivert Pharma Ltd
First posted: 2017-03-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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;

Primary outcomes:
measure: Visual Acuity
timeFrame: Part 1: 12 days time frame; Part 2: 35 days time frame
measure: Slit-lamp Biomicroscopy
timeFrame: Part 1: 12 days time frame; Part 2: 35 days time frame
measure: Drop Comfort Assessment
timeFrame: Part 1: 12 days time frame
measure: Intraocular Pressure
timeFrame: Part 1: 12 days time frame; Part 2: 35 days time frame
measure: Corneal Sensitivity
timeFrame: Part 1: 12 days time frame; Part 2: 35 days time frame
measure: Undilated Fundoscopy
timeFrame: Part 2: 35 days time frame
measure: Vital Signs - Pulse
timeFrame: Part 1: 12 days time frame; Part 2: 35 days time frame
measure: Vital Signs - O2 Saturation
timeFrame: Part 1: 12 days time frame; Part 2: 35 days time frame
measure: Vital Signs - Systolic Blood Pressure
timeFrame: Part 1: 12 days time frame; Part 2: 35 days time frame
measure: Vital Signs - Diastolic Blood Pressure
timeFrame: Part 1: 12 days time frame; Part 2: 35 days time frame
Secondary outcomes:
measure: Ocular Discomfort
timeFrame: Part 2: 35 days time frame
measure: Dry Eye Symptoms
timeFrame: Part 2: 35 days time frame
measure: Dry Eye Signs
timeFrame: Part 2: 35 days time frame
measure: Tear Film Break up Time
timeFrame: Part 2: 35 days time frame
measure: Schirmer's Test
timeFrame: Part 2: 35 days time frame
measure: Daily Symptom Assessment
timeFrame: Assessed daily between visit 3b (day 27) to visit 4b (day 35)
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: G Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: