Study of TOP1630 for Dry Eye Syndrome
THEIA-1
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
1 other identifier
interventional
202
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2019
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 7, 2019
CompletedStudy Start
First participant enrolled
February 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2019
CompletedAugust 7, 2019
August 1, 2019
3 months
February 5, 2019
August 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Ocular grittiness 6-point (0-5) scale
Ocular grittiness severity assessment
Day 29
Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
Day 29
Secondary Outcomes (5)
Ocular discomfort 5-point (0-4) scale
Day 29
Ocular dryness 6-point (0-5) scale
Day 29
Conjunctival lissamine green staining score 5-point (0-4) scale each region
Day 29
Corneal lissamine green staining score 5-point (0-4) scale each region
Day 29
Worst ocular symptom 6-point (0-5) scale
Day 29
Study Arms (2)
TOP1630 Ophthalmic Solution
EXPERIMENTALPlacebo to TOP1630 Ophthalmic Solution
PLACEBO COMPARATORInterventions
Bilateral ocular drug administration
Bilateral ocular drug administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Central Maine Eye Care
Lewiston, Maine, 04240, United States
Andover Eye Associates
Andover, Massachusetts, 01810, United States
Suite 305, 775 Paramount Drive
Raynham, Massachusetts, 02767, United States
Total Eye Care
Memphis, Tennessee, 38119, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2019
First Posted
February 7, 2019
Study Start
February 13, 2019
Primary Completion
May 14, 2019
Study Completion
May 14, 2019
Last Updated
August 7, 2019
Record last verified: 2019-08