Safety and Efficacy of TOP1630 for Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088605
• Other study ID #: TOP1630-TV-04
• Status: Completed
• Phase: Phase 2
• Start date: February 20, 2017
• Est. completion date: June 15, 2017

Study information

• Verified date: January 2024
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• TOP1630 Ophthalmic Solution
Bilateral ocular drug administration
• Placebo to TOP1630 Ophthalmic Solution
Bilateral ocular drug administration

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
ORA, Inc.	Topivert Pharma Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Ocular Discomfort	Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant)	Part 2: 35 days time frame
Secondary	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
Secondary	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
Secondary	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
Secondary	Schirmer's Test	Measurement of Schirmer test strips (mm length of moistened area after 5 minutes)	Part 2: 35 days time frame
Secondary	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)