Dry Eye Syndrome
Conditions
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.
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.
Interventions
DRUGTOP1630 0.1% Ophthalmic Solution TID OU
Bilateral ocular drug administration
DRUGPlacebo to TOP1630 0.1% Ophthalmic Solution TID OU
Bilateral ocular drug administration
Sponsors
Topivert Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular grittiness 6-point (0-5) scale | Day 29 | Ocular grittiness severity assessment |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Ocular discomfort 5-point (0-4) scale | Day 29 | Ocular discomfort severity assessment |
| Worst ocular symptom 6-point (0-5) scale | Day 29 | Most severe baseline symptom from reported daily symptoms |
| 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. |
| Ocular dryness 6-point (0-5) scale | Day 29 | Ocular dryness severity assessment |
Countries
United States
Outcome results
None listed