Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206020
Recruitment Status : Completed
First Posted : December 20, 2019
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Mitotech, SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye Syndrome
Interventions Drug: SkQ1 Vehicle Solution
Drug: SkQ1 Ophthalmic Solution
Enrollment 610
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Comparator: SkQ1 Vehicle SkQ1 Ophthalmic Solution
Hide Arm/Group Description Vehicle for SkQ1 Ophthalmic Solution SkQ1 Ophthalmic Solution (1.55µg/mL)
Period Title: Overall Study
Started 306 304
Completed 298 297
Not Completed 8 7
Reason Not Completed
Adverse Event             1             4
Protocol Violation             2             0
Withdrawal by Subject             2             0
Lost to Follow-up             2             0
Pregnancy             0             1
Unable to attend visits             1             2
Arm/Group Title Placebo Comparator: SkQ1 Vehicle SkQ1 Ophthalmic Solution Total
Hide Arm/Group Description Vehicle for SkQ1 Ophthalmic Solution SkQ1 Ophthalmic Solution (1.55µg/mL) Total of all reporting groups
Overall Number of Baseline Participants 306 304 610
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 304 participants 610 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
166
  54.2%
150
  49.3%
316
  51.8%
>=65 years
140
  45.8%
154
  50.7%
294
  48.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean (SD) Number Analyzed 306 participants 304 participants 610 participants
61.9  (11.92) 62.8  (12.58) 62.4  (12.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 304 participants 610 participants
Female
223
  72.9%
209
  68.8%
432
  70.8%
Male
83
  27.1%
95
  31.3%
178
  29.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 304 participants 610 participants
American Indian or Alaska Native
1
   0.3%
0
   0.0%
1
   0.2%
Asian
13
   4.2%
11
   3.6%
24
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.7%
2
   0.3%
Black or African American
50
  16.3%
34
  11.2%
84
  13.8%
White
241
  78.8%
253
  83.2%
494
  81.0%
More than one race
1
   0.3%
3
   1.0%
4
   0.7%
Unknown or Not Reported
0
   0.0%
1
   0.3%
1
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 306 participants 304 participants 610 participants
306 304 610
Ocular Discomfort Scale  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 306 participants 304 participants 610 participants
2.7  (1.06) 2.7  (0.98) 2.7  (1.02)
1.Primary Outcome
Title Ocular Discomfort Scale
Hide Description Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.
Time Frame From baseline to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Comparator: SkQ1 Vehicle SkQ1 Ophthalmic Solution
Hide Arm/Group Description:
Vehicle for SkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution (1.55µg/mL)
Overall Number of Participants Analyzed 306 304
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (1.36) -0.6  (1.34)
2.Primary Outcome
Title Conjunctival Fluorescein Staining
Hide Description Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining
Time Frame From baseline to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Comparator: SkQ1 Vehicle SkQ1 Ophthalmic Solution
Hide Arm/Group Description:
Vehicle for SkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution (1.55µg/mL)
Overall Number of Participants Analyzed 251 250
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.63  (1.087) -0.69  (1.150)
Time Frame From Day -7 through end of study (Day 57)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Comparator: SkQ1 Vehicle SkQ1 Ophthalmic Solution
Hide Arm/Group Description Vehicle for SkQ1 Ophthalmic Solution SkQ1 Ophthalmic Solution (1.55µg/mL)
All-Cause Mortality
Placebo Comparator: SkQ1 Vehicle SkQ1 Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/306 (0.00%)      0/304 (0.00%)    
Hide Serious Adverse Events
Placebo Comparator: SkQ1 Vehicle SkQ1 Ophthalmic Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/306 (0.65%)      2/304 (0.66%)    
Cardiac disorders     
Atrial fibrillation   0/306 (0.00%)  0 1/304 (0.33%)  1
Atrioventricular block complete   1/306 (0.33%)  1 0/304 (0.00%)  0
Gastrointestinal disorders     
Colitis ischaemic   0/306 (0.00%)  0 1/304 (0.33%)  1
Renal and urinary disorders     
Nephrolithiasis   1/306 (0.33%)  1 0/304 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Comparator: SkQ1 Vehicle SkQ1 Ophthalmic Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/306 (6.21%)      20/304 (6.58%)    
Eye disorders     
Visual acuity reduced   6/306 (1.96%)  6 5/304 (1.64%)  5
General disorders     
Instillation site pain   13/306 (4.25%)  18 15/304 (4.93%)  19
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor will have the final decision regarding the manuscript and publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Operating Officer
Organization: Mitotech S.A.
Phone: +352621692785
EMail: info@mitotechpharma.com
Layout table for additonal information
Responsible Party: Mitotech, SA
ClinicalTrials.gov Identifier: NCT04206020    
Other Study ID Numbers: 19-110-0011
First Submitted: December 18, 2019
First Posted: December 20, 2019
Results First Submitted: December 20, 2021
Results First Posted: January 19, 2022
Last Update Posted: January 19, 2022