Study of TOP1630 for Dry Eye Syndrome (THEIA-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03833388|
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : March 28, 2019
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||February 13, 2019|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
|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
- Ocular grittiness 6-point (0-5) scale [ Time Frame: Day 29 ]Ocular grittiness severity assessment
- Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region [ Time Frame: Day 29 ]Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
- Ocular discomfort 5-point (0-4) scale [ Time Frame: Day 29 ]Ocular discomfort severity assessment
- Ocular dryness 6-point (0-5) scale [ Time Frame: Day 29 ]Ocular dryness severity assessment
- Conjunctival lissamine green staining score 5-point (0-4) scale each region [ Time Frame: Day 29 ]Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.
- Corneal lissamine green staining score 5-point (0-4) scale each region [ Time Frame: Day 29 ]Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.
- Worst ocular symptom 6-point (0-5) scale [ Time Frame: Day 29 ]Most severe baseline symptom from reported daily symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833388
|United States, Maine|
|Central Maine Eye Care||Recruiting|
|Lewiston, Maine, United States, 04240|
|Contact: Dr Lonsdale 207-783-9670 email@example.com|
|United States, Massachusetts|
|Andover Eye Associates||Recruiting|
|Andover, Massachusetts, United States, 01810|
|Contact: Dr Torkildsen 784-750-0705 firstname.lastname@example.org|
|Suite 305, 775 Paramount Drive||Recruiting|
|Raynham, Massachusetts, United States, 02767|
|Contact: Dr Kenyon 978-685-8900 email@example.com|
|United States, Tennessee|
|Total Eye Care||Recruiting|
|Memphis, Tennessee, United States, 38119|
|Contact: Dr McLaurin 901-761-4620 firstname.lastname@example.org|