THEIA-1: Study of TOP1630 for Dry Eye Syndrome

• Sponsor: Topivert Pharma Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03833388
• Collaborator: (none)
• Enrollment: 202
• Locations: 4
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site: 50.5
• Patients Per Site Per Month: 17.1

Study Details

Study Description

Brief Summary

In subjects with Dry Eye Syndrome (DES):

The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: TOP1630 0.1% Ophthalmic Solution TID OU; Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU	Phase 2/Phase 3

Detailed Description

This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES).

Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 202 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome
• Actual Study Start Date: Feb 13, 2019
• Actual Primary Completion Date: May 14, 2019
• Actual Study Completion Date: May 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TOP1630 Ophthalmic Solution	Drug: TOP1630 0.1% Ophthalmic Solution TID OU; Bilateral ocular drug administration
Placebo Comparator: Placebo to TOP1630 Ophthalmic Solution	Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU; Bilateral ocular drug administration

Outcome Measures

Primary Outcome Measures

1. Ocular grittiness 6-point (0-5) scale [Day 29]

   Ocular grittiness severity assessment

2. Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region [Day 29]

   Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.

Secondary Outcome Measures

1. Ocular discomfort 5-point (0-4) scale [Day 29]

   Ocular discomfort severity assessment

2. Ocular dryness 6-point (0-5) scale [Day 29]

   Ocular dryness severity assessment

3. Conjunctival lissamine green staining score 5-point (0-4) scale each region [Day 29]

   Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.

4. Corneal lissamine green staining score 5-point (0-4) scale each region [Day 29]

   Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.

5. Worst ocular symptom 6-point (0-5) scale [Day 29]

   Most severe baseline symptom from reported daily symptoms

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;

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	Central Maine Eye Care	Lewiston	Maine	United States	04240
2	Andover Eye Associates	Andover	Massachusetts	United States	01810
3	Suite 305, 775 Paramount Drive	Raynham	Massachusetts	United States	02767
4	Total Eye Care	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• Topivert Pharma Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Topivert Pharma Ltd
• ClinicalTrials.gov Identifier: NCT03833388
• Other Study ID Numbers: TOP1630-TV-05
• First Posted: Feb 7, 2019
• Last Update Posted: Aug 7, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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 Aug 7, 2019