Safety and Efficacy of TOP1630 for Dry Eye Syndrome

• Sponsor: Topivert Pharma Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03088605
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.8
• Patients Per Site Per Month: 18.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: TOP1630 Ophthalmic Solution; Drug: Placebo to TOP1630 Ophthalmic Solution	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 20, 2017
• Actual Primary Completion Date: Jun 15, 2017
• Actual Study Completion Date: Jun 15, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. Vital Signs [Part 1: 12 days time frame; Part 2: 35 days time frame]

   Blood Pressure, Pulse and SPo2 will be performed to assess changes from baseline

4. Drop Comfort Assessment [Part 1: 12 days time frame]

   The comfort of the eye drop will be performed to assess changes from baseline

5. 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

6. 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

7. Undilated Fundoscopy [Part 2: 35 days time frame]

   Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline

8. Adverse events [Part 1: 12 days time frame; Part 2: 35 days time frame]

   Adverse event questioning

Secondary Outcome Measures

1. Ocular discomfort [Part 2: 35 days time frame]

   Ocular discomfort severity assessments

2. Dry eye symptoms [Part 2: 35 days time frame]

   Dry eye syndrome symptom assessments

3. Dry eye signs [Part 2: 35 days time frame]

   Dry eye syndrome conjunctival staining assessments

4. Tear film break up time [Part 2: 35 days time frame]

   Tear film break up time measured after instillation of sodium fluorescein solution

5. Schirmer's test [Part 2: 35 days time frame]

   Measurement of Schirmer test strips

6. Impression cytology [Part 2: 35 days time frame]

   Impression cytology

7. Daily symptom assessment [Part 2: 35 days time frame]

   Daily symptom assessment using diary cards

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• Topivert Pharma Ltd

Investigators

• Principal Investigator: G Torkildsen, MD, Andover Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Topivert Pharma Ltd
• ClinicalTrials.gov Identifier: NCT03088605
• Other Study ID Numbers: TOP1630-TV-04
• First Posted: Mar 23, 2017
• Last Update Posted: Sep 26, 2018
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Sep 26, 2018