Safety and Efficacy of TOP1630 for Dry Eye Syndrome

Phase 2

Completed

Conditions: Dry Eye Syndrome

Interventions: Drug: TOP1630 Ophthalmic Solution
Drug: Placebo to TOP1630 Ophthalmic Solution

Registration Number: NCT03088605

Lead Sponsor: ORA, Inc.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 69

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;

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	TOP1630 Ophthalmic Solution	TOP1630 Ophthalmic Solution
Placebo	Placebo to TOP1630 Ophthalmic Solution	Placebo (Vehicle) Ophthalmic Solution

Primary Outcome Measures

Name	Time	Method
Undilated Fundoscopy	Part 2: 35 days time frame	Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities
Visual Acuity	Part 1: 12 days time frame; Part 2: 35 days time frame	Visual Acuity will be measured using the EDTRS chart to assess changes from baseline
Vital Signs - Pulse	Part 1: 12 days time frame; Part 2: 35 days time frame	Changes in vital signs is performed to assess changes from baseline
Vital Signs - O2 Saturation	Part 1: 12 days time frame; Part 2: 35 days time frame	Changes in vital signs is performed to assess changes from baseline
Corneal Sensitivity	Part 1: 12 days time frame; Part 2: 35 days time frame	The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6
Vital Signs - Systolic Blood Pressure	Part 1: 12 days time frame; Part 2: 35 days time frame	Changes in vital signs is performed to assess changes from baseline
Vital Signs - Diastolic Blood Pressure	Part 1: 12 days time frame; Part 2: 35 days time frame	Changes in vital signs is performed to assess changes from baseline
Drop Comfort Assessment	Part 1: 12 days time frame	The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable
Slit-lamp Biomicroscopy	Part 1: 12 days time frame; Part 2: 35 days time frame	Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities
Intraocular Pressure	Part 1: 12 days time frame; Part 2: 35 days time frame	a non-contact tonometer will be used to perform IOP to assess changes from baseline.

Secondary Outcome Measures

Name	Time	Method
Ocular Discomfort	Part 2: 35 days time frame	Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant)
Dry Eye Symptoms	Part 2: 35 days time frame	Dry eye syndrome symptom assessment Scale (grittiness) (0-5 scale where 0 = none and 5 = worst)
Dry Eye Signs	Part 2: 35 days time frame	Dry eye syndrome staining Score assessments (total lissamine green staining score, 0-20 where 0 = no staining)
Tear Film Break up Time	Part 2: 35 days time frame	Tear film break up time measured (in seconds) after instillation of sodium fluorescein solution
Schirmer's Test	Part 2: 35 days time frame	Measurement of Schirmer test strips (mm length of moistened area after 5 minutes)
Daily Symptom Assessment	Assessed daily between visit 3b (day 27) to visit 4b (day 35)	Daily symptom assessment using diary cards - outcome for worst symptom, ie symptom with highest severity score at baseline for each patient; calculated using the daily average between visit 3b to visit 4b Ora Calibra Ocular Discomfort \& 4-Symptom Questionnaire (0-5 scale where 0 = none and 5 = worst)