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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

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: NCT02121301
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Mitotech, SA

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.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: SkQ1 Drug: Placebo SkQ1 (Vehicle) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Center, Randomized, Double-Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and During Challenge in the CAE(SM) Model for the Treatment of Dry Eye Syndrome
Study Start Date : April 2014
Actual Primary Completion Date : May 2014

Arm Intervention/treatment
Experimental: Arm 1
Low Dose - SkQ1
Drug: SkQ1
Experimental: Arm 2
High Dose - SkQ1
Drug: SkQ1
Placebo Comparator: Arm 3
Placebo - SkQ1 (Vehicle)
Drug: Placebo SkQ1 (Vehicle)



Primary Outcome Measures :
  1. Fluorescein Staining [ Time Frame: Day 29 ]
  2. Worst Dry Eye Symptom [ Time Frame: Day 29 ]

Other Outcome Measures:
  1. Number of participants with Adverse events [ Time Frame: Day 29 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121301


Locations
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United States, Massachusetts
Andover, Massachusetts, United States
Sponsors and Collaborators
Mitotech, SA
ORA, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mitotech, SA
ClinicalTrials.gov Identifier: NCT02121301     History of Changes
Other Study ID Numbers: 13-110-0006
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014
Keywords provided by Mitotech, SA:
Dry Eye
Dry Eye Syndrome
SkQ1
KCS
Keratoconjunctivitis
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions