Keratoconjunctivitis SiccaPhase 1NCT01733992
A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
A Phase 1 study testing R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5% and R348 Ophthalmic Solution, 1.0% in people with Keratoconjunctivitis Sicca, run by Rigel Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5% and R348 Ophthalmic Solution, 1.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate Keratoconjunctivitis Sicca.
- A corrected visual acuity in both eyes of 20/40 or better.
- An intraocular pressure of < 21 mm Hg with a difference between eyes of < 6 mm Hg.
Who cannot join
- History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day.
- History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.
- History of herpes simplex keratitis at any time.
- Current ocular allergy symptoms.
- Recent use of eye medications such as steroids or cyclosporine
- Refractive eye surgery within 12 months of the first dosing day.
Show all 14Show fewer
- Other eye surgeries within 4 months of the first dosing day.
- Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
- Receipt of any blood or blood products within 90 days prior to the first dosing day.
- Participation in any clinical study within 30 days prior to the first dosing day.
- History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor.
- Positive for hepatitis B, hepatitis C or HIV.
- Smoked regularly within 12 months of first dosing day.
- History of substance abuse, drug addiction or alcoholism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate Keratoconjunctivitis Sicca
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.
Read the detailed description
This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5%, R348 Ophthalmic Solution, 1.0%, Placebo
- Medical subject headings
- Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R348 Ophthalmic Solution, 0.2%Drug
Also called R932348
R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
R348 Ophthalmic Solution, 0.5%Drug
Also called R932348
R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
R348 Ophthalmic Solution, 1.0%Drug
Also called R932348
R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
PlaceboDrug
Placebo, single and multiple ascending dose
| Study group | Role | What they receive |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | Active comparator | R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. Receives: Drug: R348 Ophthalmic Solution, 0.2%; Drug: Placebo |
| R348 Ophthalmic Solution, 0.5% | Active comparator | R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. Receives: Drug: R348 Ophthalmic Solution, 0.5%; Drug: Placebo |
| R348 Ophthalmic Solution, 1.0% | Active comparator | R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. Receives: Drug: R348 Ophthalmic Solution, 1.0%; Drug: Placebo |
| Placebo | Placebo comparator | Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal fluorescein staining
Measured: Baseline and Visits 4, 8 and 12
Secondary outcomes (1)
Change in conjunctival lissamine green staining
Measured: Baseline and Visits 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733992
- Sponsor's protocol ID
- C-932348-002
- Status last verified
- Jul 2014
- First submitted
- 21 Nov 2012
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate Keratoconjunctivitis Sicca
- ClinicalTrials.gov ID
- NCT01733992
- Acronym / sponsor ID
- C-932348-002
- Conditions
- Keratoconjunctivitis Sicca
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
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 determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.
Detailed description
This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | Active comparator | Drug: R348 Ophthalmic Solution, 0.2%, Drug: PlaceboR348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. |
| R348 Ophthalmic Solution, 0.5% | Active comparator | Drug: R348 Ophthalmic Solution, 0.5%, Drug: PlaceboR348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. |
| R348 Ophthalmic Solution, 1.0% | Active comparator | Drug: R348 Ophthalmic Solution, 1.0%, Drug: PlaceboR348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate Keratoconjunctivitis Sicca.
- A corrected visual acuity in both eyes of 20/40 or better.
- An intraocular pressure of < 21 mm Hg with a difference between eyes of < 6 mm Hg.
Key exclusion criteria (14 listed)
- History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day.
- History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.
- History of herpes simplex keratitis at any time.
- Current ocular allergy symptoms.
- Recent use of eye medications such as steroids or cyclosporine
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 |
|---|---|---|
| R348 Ophthalmic Solution, 0.2%Also: R932348R348 Ophthalmic Solution, 0.2% single and multiple ascending dose | Drug | R348 Ophthalmic Solution, 0.2% |
| R348 Ophthalmic Solution, 0.5%Also: R932348R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose | Drug | R348 Ophthalmic Solution, 0.5% |
| R348 Ophthalmic Solution, 1.0%Also: R932348R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose | Drug | R348 Ophthalmic Solution, 1.0% |
| PlaceboPlacebo, single and multiple ascending dose | Drug | Placebo, R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5%, R348 Ophthalmic Solution, 1.0% |
Primary outcome
Change in corneal fluorescein staining
Time frame: Baseline and Visits 4, 8 and 12
1 secondary outcome
Change in conjunctival lissamine green staining
Time frame: Baseline and Visits 4, 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
Related trials for Keratoconjunctivitis Sicca
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
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
Andover Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5% and R348 Ophthalmic Solution, 1.0% in people with Keratoconjunctivitis Sicca, run by Rigel Pharmaceuticals 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 3 inclusion and 14 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 4 Aug 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in corneal fluorescein staining (time frame: Baseline and Visits 4, 8 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2014.