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Clinical trial

Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Signs and Symptoms of Dry Eye Disease

ID
Name
ILUT-401-DED
Description
This is a Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Signs and Symptoms of Dry Eye Disease.
Trial arms
Trial start
2022-01-03
Estimated PCD
2022-07-27
Trial end
2022-07-27
Status
Completed
Phase
Early phase I
Treatment
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 1
Arms:
Pilocarpine Ophthalmic Topical Cream, Dose 1
Other names:
GLK-301
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 2
Arms:
Pilocarpine Ophthalmic Topical Cream, Dose 2
Other names:
GLK-301
Pilocarpine Ophthalmic Topical Cream, Dose 3
Pilocarpine Ophthalmic Topical Cream, Dose 3
Arms:
Pilocarpine Ophthalmic Topical Cream, Dose 3
Other names:
GLK-301
Placebo Ophthalmic Topical Cream
Placebo Ophthalmic Topical Cream
Arms:
Placebo Ophthalmic Topical Cream
Other names:
Placebo
Size
226
Primary endpoint
Mean change from baseline in the VAS score at Day 28 visit.
Baseline and Day 28
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Baseline and Day 28
Eligibility criteria
Inclusion Criteria: * Male or female, 18 years of age or older at the Screening Visit * Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form * Diagnosis of dry eye Exclusion Criteria: * Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation * History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc. * History of, or active iritis or uveitis in either eye * Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 226, 'type': 'ACTUAL'}}
Updated at
2023-07-12

1 organization

3 products

2 indications

Organization
Glaukos
Product
Pilocarpine Ophthalmic Topical Cream
Indication
Dry Eye Syndrome
Indication
Keratoconjunctivitis sicca
Product
Placebo Ophthalmic Topical Cream
Product
Pilocarpine