Keratoconjunctivitis SiccaPhase 2NCT02121301
A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
A Phase 2 study testing Low Dose 0.155µg/mL SkQ1 ophthalmic solution and High Dose 1.55µg/mL SkQ1 ophthalmic solution in people with Keratoconjunctivitis Sicca, run by Mitotech, SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- Low Dose 0.155µg/mL SkQ1 ophthalmic solution and High Dose 1.55µg/mL SkQ1 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lawrence General Hospital
Andover, Massachusetts, 01841
About this study
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
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.
Read the 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.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- Low Dose 0.155µg/mL SkQ1 ophthalmic solution, High Dose 1.55µg/mL SkQ1 ophthalmic solution, Placebo (Vehicle) opthalmic solution
- Keywords
- Dry Eye, Dry Eye Syndrome, SkQ1, Keratoconjunctivitis, Dry Eye Disease
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes, Keratoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose 0.155µg/mL SkQ1 ophthalmic solutionDrug
eyedrops
High Dose 1.55µg/mL SkQ1 ophthalmic solutionDrug
eyedrops
Placebo (Vehicle) opthalmic solutionDrug
eyedrops
| Study group | Role | What they receive |
|---|---|---|
| Low Dose SkQ1 | Experimental | Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days Receives: Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution |
| High Dose SkQ1 | Experimental | Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days Receives: Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution |
| Placebo (vehicle) | Placebo comparator | Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days Receives: Drug: Placebo (Vehicle) opthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitotech, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Lawrence General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121301
- Sponsor's protocol ID
- 13-110-0006
- Status last verified
- Oct 2020
- First submitted
- 17 Apr 2014
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26733410
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02121301
- Acronym / sponsor ID
- 13-110-0006
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- Dry Eye, Dry Eye Syndrome, SkQ1, Keratoconjunctivitis, Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Mitotech, SAIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose SkQ1 | Experimental | Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solutionDrug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days |
| High Dose SkQ1 | Experimental | Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solutionDrug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days |
| Placebo (vehicle) | Placebo comparator | Drug: Placebo (Vehicle) opthalmic solutionDrug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose 0.155µg/mL SkQ1 ophthalmic solutioneyedrops | Drug | Low Dose SkQ1 |
| High Dose 1.55µg/mL SkQ1 ophthalmic solutioneyedrops | Drug | High Dose SkQ1 |
| Placebo (Vehicle) opthalmic solutioneyedrops | Drug | Placebo (vehicle) |
Primary outcome
Inferior Corneal Fluorescein Staining
Time frame: Day 29
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
Time frame: Day 29
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26733410Petrov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Torkildsen, MD principal investigator
Lawrence General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose 0.155µg/mL SkQ1 ophthalmic solution and High Dose 1.55µg/mL SkQ1 ophthalmic solution in people with Keratoconjunctivitis Sicca, run by Mitotech, SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inferior Corneal Fluorescein Staining (time frame: Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.