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A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)

Primary Purpose

Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low Dose 0.155µg/mL SkQ1 ophthalmic solution
High Dose 1.55µg/mL SkQ1 ophthalmic solution
Placebo (Vehicle) opthalmic solution
Sponsored by
Mitotech, SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring Dry Eye, Dry Eye Syndrome, SkQ1, Keratoconjunctivitis, Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be male or female of any race, at least 18 years of age
  • Have provided written informed consent
  • Have a reported history of dry eye syndrome
  • Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

  • Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
  • Have previously had LASIK surgery within the last 12 months
  • Have used Restasis® within 30 days of Visit 1
  • Be a woman who is pregnant, nursing or planning a pregnancy
  • Be unwilling to submit a urine pregnancy test if of childbearing potential
  • Have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride
  • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1
  • 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

Sites / Locations

  • Lawrence General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose SkQ1

High Dose SkQ1

Placebo (vehicle)

Arm Description

Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days

Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days

Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days

Outcomes

Primary Outcome Measures

Inferior Corneal Fluorescein Staining
The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29
Worst Symptom Based on Diary Data
Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2014
Last Updated
October 12, 2020
Sponsor
Mitotech, SA
Collaborators
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02121301
Brief Title
A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
Official Title
Phase 2, Single-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophth Sol'n in the Environment and During Challenge in the Controlled Adverse Environment (CAE) Model for the Treatment of DES
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitotech, SA
Collaborators
ORA, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.
Detailed Description
Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution). The following primary endpoints were tested: Corneal Fluorescein staining in the inferior region Pre-CAE at Visit 4 (Day 29), as measured by the Ora Calibra Scale in the worst eye at baseline; Worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between Visit 1 and Visit 2) evaluated over the seven days preceding Visit 4 (not including day of visit) during the treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
Keywords
Dry Eye, Dry Eye Syndrome, SkQ1, Keratoconjunctivitis, Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose SkQ1
Arm Type
Experimental
Arm Description
Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
Arm Title
High Dose SkQ1
Arm Type
Experimental
Arm Description
Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
Arm Title
Placebo (vehicle)
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Low Dose 0.155µg/mL SkQ1 ophthalmic solution
Intervention Description
eyedrops
Intervention Type
Drug
Intervention Name(s)
High Dose 1.55µg/mL SkQ1 ophthalmic solution
Intervention Description
eyedrops
Intervention Type
Drug
Intervention Name(s)
Placebo (Vehicle) opthalmic solution
Intervention Description
eyedrops
Primary Outcome Measure Information:
Title
Inferior Corneal Fluorescein Staining
Description
The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29
Time Frame
Day 29
Title
Worst Symptom Based on Diary Data
Description
Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms.
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be male or female of any race, at least 18 years of age Have provided written informed consent Have a reported history of dry eye syndrome Have a history of use or desire to use eye drops for dry eye Exclusion Criteria: Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters Have previously had LASIK surgery within the last 12 months Have used Restasis® within 30 days of Visit 1 Be a woman who is pregnant, nursing or planning a pregnancy Be unwilling to submit a urine pregnancy test if of childbearing potential Have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Lawrence General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lawrence General Hospital
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01841
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26733410
Citation
Petrov A, Perekhvatova N, Skulachev M, Stein L, Ousler G. SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model. Adv Ther. 2016 Jan;33(1):96-115. doi: 10.1007/s12325-015-0274-5. Epub 2016 Jan 5.
Results Reference
derived

Learn more about this trial

A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)

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