Back to resultsOCS-01 in Treating Inflammation and Pain in Post-cataract Patients (SKYGGN)
Primary Purpose
Inflammation Corneal, Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation Corneal focused on measuring post-cataract,, inflammation, Pain, post-surgery, corticosteroid, anterior chamber cells, flares
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent, approved by the appropriate ethics committee;
- Be able to comply with the study requirements and visit schedule;
- Be at least 18 years of age of either sex or any race;
- Be planning to undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
- Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 [18 to 30 hours post-uncomplicated cataract surgery without vitreous loss]);
- Have a pin-hole visual acuity (VA) without any other correction > 20 letters (approximately 20/400) in the operative eye and > 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 [prior to surgery]);
- Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 [prior to surgery]),
Exclusion Criteria:
- Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
- Be monocular;
- Have any intraocular inflammation (e.g. white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit lamp examination;
- Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye;
- Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and other pain medications), or immunomodulating agents, systemically or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study.
Sites / Locations
- Medical cennre
- Medical center
- Medical center
- Medical center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
OCS-01 1.5% mg/mL QD
OCS-01 1.5% mg/mL BID
Placebo (Vehicle) BID
Arm Description
eye drops
eye drops
eye drops
Outcomes
Primary Outcome Measures
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')
Absence of anterior chamber cells as measured by slit beam with fluorescein. The anterior chamber cell count was recorded as the actual number of cells observed if ≤10 cells were seen, otherwise a range was reported. The observed anterior chamber cell count at Visit 6 was used and categorized for analysis as follows:
Absence of anterior chamber cells: anterior chamber cell count of 0 / Grade 0
Presence of anterior chamber cells: anterior chamber cell count of 1 or more / Grade 1, 2, 3, or 4
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')
Absence of pain as assessed by Ocular Pain Grading Scale (Min 0, Max 10) in which 0 is no pain and 10 is the worst possible. Ocular pain was assessed by the patient at screening and at each follow-up visit, utilizing a numerical pain rating scale. Scores ranged from 0 to 10, where 0 = No Pain and 10 = Severe Pain, such that larger scores corresponded to higher levels of pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04130802
Brief Title
OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
Acronym
SKYGGN
Official Title
A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of Two Doses of OCS 01 Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The DX-216 trial is a randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle in the treatment of inflammation and pain following cataract surgery. The primary objective is to evaluate the efficacy and safety of OCS-01 compared to placebo and the secondary objective is to evaluate the optimal dosing frequency (once a day [QD] or twice a day [BID]).
Detailed Description
This is a multi-center, randomized, double-masked, placebo (vehicle)-controlled study, designed to evaluate the efficacy and safety of OCS-01 ophthalmic suspension (QD versus BID) compared to placebo in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1:1 to receive OCS-01 QD, OCS-01 BID, or placebo BID. Subjects will dose 1 drop in the study eye BID for 14 days, beginning 1 day post-surgery in the operated eye. The study will last up to 24 days, including a follow-up visit at Visit 7 (Day 22 ± 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation Corneal, Pain, Postoperative
Keywords
post-cataract,, inflammation, Pain, post-surgery, corticosteroid, anterior chamber cells, flares
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle
Masking
ParticipantOutcomes Assessor
Masking Description
For masking purposes, each dosing box and the pouches within it will be labeled either "AM" or "PM." Dosing boxes and pouches will be labeled this way regardless of whether the product within the 2 boxes is the same (i.e. OCS-01 BID and placebo treatment arms) or different (i.e. OCS-01 QD).
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCS-01 1.5% mg/mL QD
Arm Type
Experimental
Arm Description
eye drops
Arm Title
OCS-01 1.5% mg/mL BID
Arm Type
Experimental
Arm Description
eye drops
Arm Title
Placebo (Vehicle) BID
Arm Type
Placebo Comparator
Arm Description
eye drops
Intervention Type
Drug
Intervention Name(s)
OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
Other Intervention Name(s)
DexNP
Intervention Description
OCS-01 eye drops
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Vehicle eye drops
Primary Outcome Measure Information:
Title
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')
Description
Absence of anterior chamber cells as measured by slit beam with fluorescein. The anterior chamber cell count was recorded as the actual number of cells observed if ≤10 cells were seen, otherwise a range was reported. The observed anterior chamber cell count at Visit 6 was used and categorized for analysis as follows:
Absence of anterior chamber cells: anterior chamber cell count of 0 / Grade 0
Presence of anterior chamber cells: anterior chamber cell count of 1 or more / Grade 1, 2, 3, or 4
Time Frame
at Day 15 (visit 6)
Title
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')
Description
Absence of pain as assessed by Ocular Pain Grading Scale (Min 0, Max 10) in which 0 is no pain and 10 is the worst possible. Ocular pain was assessed by the patient at screening and at each follow-up visit, utilizing a numerical pain rating scale. Scores ranged from 0 to 10, where 0 = No Pain and 10 = Severe Pain, such that larger scores corresponded to higher levels of pain.
Time Frame
at Day 4 (visit 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent, approved by the appropriate ethics committee;
Be able to comply with the study requirements and visit schedule;
Be at least 18 years of age of either sex or any race;
Be planning to undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 [18 to 30 hours post-uncomplicated cataract surgery without vitreous loss]);
Have a pin-hole visual acuity (VA) without any other correction > 20 letters (approximately 20/400) in the operative eye and > 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 [prior to surgery]);
Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 [prior to surgery]),
Exclusion Criteria:
Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
Be monocular;
Have any intraocular inflammation (e.g. white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit lamp examination;
Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye;
Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and other pain medications), or immunomodulating agents, systemically or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study.
Facility Information:
Facility Name
Medical cennre
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Medical center
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97471
Country
United States
Facility Name
Medical center
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Medical center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26201996
Citation
Ohira A, Hara K, Johannesson G, Tanito M, Asgrimsdottir GM, Lund SH, Loftsson T, Stefansson E. Topical dexamethasone gamma-cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema. Acta Ophthalmol. 2015 Nov;93(7):610-5. doi: 10.1111/aos.12803. Epub 2015 Jul 23.
Results Reference
background
PubMed Identifier
21896859
Citation
Tanito M, Hara K, Takai Y, Matsuoka Y, Nishimura N, Jansook P, Loftsson T, Stefansson E, Ohira A. Topical dexamethasone-cyclodextrin microparticle eye drops for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7944-8. doi: 10.1167/iovs.11-8178.
Results Reference
background
PubMed Identifier
24373641
Citation
Johannesson G, Moya-Ortega MD, Asgrimsdottir GM, Lund SH, Thorsteinsdottir M, Loftsson T, Stefansson E. Kinetics of gamma-cyclodextrin nanoparticle suspension eye drops in tear fluid. Acta Ophthalmol. 2014 Sep;92(6):550-6. doi: 10.1111/aos.12334. Epub 2013 Dec 24.
Results Reference
background
PubMed Identifier
16217662
Citation
Saari KM, Nelimarkka L, Ahola V, Loftsson T, Stefansson E. Comparison of topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for postcataract inflammation. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):620-6. doi: 10.1007/s00417-005-0124-2. Epub 2005 Oct 11.
Results Reference
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OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
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