Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04498182
Other study ID # AR15512-CS201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 10, 2020
Est. completion date July 20, 2021

Study information

Verified date July 2022
Source Aerie Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5 / Study Exit). Safety will be assessed at all study visits. All subjects will be exposed to the Controlled Adverse Environment (CAE®) at the Screening, Baseline, Day 28 and Day 84 visits. Only subjects who qualify based on inclusion/exclusion criteria, will be enrolled in the study and randomized at a 1:1:1 ratio within each site, to receive AR-15512 0.0014%, AR-15512 0.003% or AR-15512 vehicle to be administered as 1 drop in each eye twice daily for 84 days.


Recruitment information / eligibility

Status Completed
Enrollment 369
Est. completion date July 20, 2021
Est. primary completion date July 20, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - Male or female, 30 years of age or older at the Screening visit - Signs of DED at the Screening and Baseline visits assessed by corneal staining and Schirmer test - Symptoms of DED at both Screening and Baseline visits assessed by SANDE questionnaire and ODS-VAS - BCVA 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits Exclusion Criteria: - History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety. - Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension), which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation. - History of ocular surgery within 1 year prior to the Screening visit. - Corneal transplant in either or both eyes. - Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study. - Punctal or intracanalicular plug present in either eyelid within 1 year prior to the Screening visit or anticipated plug insertion or occlusion at any time during the study. - Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study. - Regular use of any topical ocular medications (including use of ocular cyclosporine or other prescription ophthalmic solution for DED, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents, glaucoma medications or other over-the-counter, herbal, prescription, any topical antibiotics, topical antihistamines, mast stabilizers, or nutritional supplements with the exception of artificial tears), within 30 days prior to the Screening visit or anticipated use during the study. Note: Occasional (as needed) >24 hours prior to the Screening Visit may be permitted - Use of medications associated with the treatment of severe DED and/or Meibomian gland disease such as oral pilocarpine, oral cevimeline, oral macrolides, oral tetracyclines, oral tetracycline derivatives, and oral retinoids within 90 days prior to the Baseline visit or anticipated use during the study - Use of systemic corticosteroids started < 90 days prior to the Baseline Visit or a change in dosage is anticipated during the study. Note: Non-ocular topically applied corticosteroids (including nasal sprays and inhalers) will be permitted during the study and the dose is not required to be stable. - Use of TrueTear® within 45 days of the Screening visit or anticipated use during the study. - Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study. - Use of systemic immunomodulators started < 90 days prior to the Baseline visit or a change in dosage is anticipated during the study. - Any systemic medication known to cause ocular drying (ex/antihistamines, anti-depressants, beta-blockers) started < 14 days prior to the Screening visit or a change in dosage is anticipated during the study. Note: Occasional (as needed) use of medications such as systemic antihistamines will be permitted - Diagnosis of recurrent, ongoing, or active ocular infection including, but not limited to herpes simplex or zoster, vaccinia, varicella, tuberculosis of the eye, acanthamoeba, or fungal disease. - History or presence of significant systemic disease.

Study Design


Intervention

Drug:
AR15512
Administered via topical ocular instillation, one drop per eye, twice daily for 84 days. Both eyes will be treated.
Vehicle
Administered via topical ocular instillation, one drop per eye, twice daily for 84 days. Both eyes will be treated.

Locations

Country Name City State
United States Principal Investigator Andover Massachusetts
United States Principal Investigator Carmel Indiana
United States Principal Investigator Colorado Springs Colorado
United States Principal Investigator Hamel Minnesota
United States Principal Investigator Indianapolis Indiana
United States Principal Investigator Kansas City Missouri
United States Principal Investigator Layton Utah
United States Principal Investigator Louisville Kentucky
United States Principal Investigator Lynchburg Virginia
United States Principal Investigator Memphis Tennessee
United States Principal Investigator Newport Beach California
United States Principal Investigator Phoenix Arizona
United States Principal Investigator Raynham Massachusetts
United States Principal Investigator Shelby North Carolina
United States Principal Investigator Smyrna Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ocular Discomfort Score (ODS) on a Visual Analogue Scale (VAS) from 0 (no ocular discomfort) to 100 (maximum ocular discomfort) millimeters Improvement from baseline in pre-Controlled Adverse Environment (CAE) ODS-VAS where a lower score is indicative of a better outcome. 28 days
Primary Anesthetized Schirmer Test from 0 to 35 millimeters Improvement from baseline in pre-Controlled Adverse Environment (CAE) anesthetized Schirmer score where a higher score is indicative of a better outcome. 28 days
See also
  Status Clinical Trial Phase
Completed NCT03216096 - Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease Phase 1
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT04656197 - The Ocular Microbiome in Patients With Dry Eye Disease
Completed NCT05031806 - Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease Phase 1
Completed NCT03688802 - Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation Phase 2
Completed NCT05213156 - Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease Phase 4
Completed NCT04548427 - Study to Evaluate the Efficacy and Safety of CKD-352 Phase 3
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Completed NCT02254265 - Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca Phase 2/Phase 3
Completed NCT00395759 - The Visual Effect of an Investigational Artificial Tear in the Tear Layer. N/A
Completed NCT00680108 - A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution Phase 2
Recruiting NCT06064071 - Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD N/A
Completed NCT04139122 - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease Phase 1/Phase 2
Not yet recruiting NCT06375343 - Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® Phase 1
Completed NCT01468168 - A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients Phase 2
Completed NCT01014078 - A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease Phase 4
Completed NCT00799682 - Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z® Phase 4
Completed NCT05082974 - Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK) Phase 3
Recruiting NCT06146881 - Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia Phase 2
Completed NCT03292809 - CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) Phase 2/Phase 3