Safety and Efficacy of TOP1630 for Dry Eye Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: TOP1630 Ophthalmic Solution; Drug: Placebo to TOP1630 Ophthalmic Solution

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; TOP1630 Ophthalmic Solution	Drug: TOP1630 Ophthalmic Solution; Bilateral ocular drug administration
Placebo Comparator: Placebo; Placebo (Vehicle) Ophthalmic Solution	Drug: Placebo to TOP1630 Ophthalmic Solution; Bilateral ocular drug administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Discomfort	Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant)	Part 2: 35 days time frame
Dry Eye Symptoms	Dry eye syndrome symptom assessment Scale (grittiness) (0-5 scale where 0 = none and 5 = worst)	Part 2: 35 days time frame
Dry Eye Signs	Dry eye syndrome staining Score assessments (total lissamine green staining score, 0-20 where 0 = no staining)	Part 2: 35 days time frame
Tear Film Break up Time	Tear film break up time measured (in seconds) after instillation of sodium fluorescein solution	Part 2: 35 days time frame
Schirmer's Test	Measurement of Schirmer test strips (mm length of moistened area after 5 minutes)	Part 2: 35 days time frame
Daily Symptom Assessment	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)	Assessed daily between visit 3b (day 27) to visit 4b (day 35)

Collaborators and Investigators

• Sponsor: ORA, Inc.
• Collaborators: Topivert Pharma Ltd
• Investigators: Principal Investigator: G Torkildsen, MD, Andover Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): June 15, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: TOP1630-TV-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No