Dry Eye SyndromesPhase 2NCT01135511
A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
A Phase 2 study testing CP-690,550 Eye drops and Sodium Hyaluronate in people with Dry Eye Syndromes, run by Pfizer at 28 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- CP-690,550 Eye drops and Sodium Hyaluronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Jul 2010to Apr 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective symptoms of dry eye for at least 6 months
- Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)
Who cannot join
- Women who are nursing, pregnant or planning pregnancy during the study
- Participation in other studies within 30 days of screening visit
- Ocular disorders that may confound interpretation of study results
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
Japan22 sites
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo
Pfizer Investigational Site
Fuji, Shizuoka
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Hamura, Tokyo
Pfizer Investigational Site
Ichinomiya, Aichi-ken
Pfizer Investigational Site
Kyoto, Kyoto
Pfizer Investigational Site
Minato-ku, Tokyo
Pfizer Investigational Site
Narashino, Chiba
Pfizer Investigational Site
Numazu, Shizuoka
Pfizer Investigational Site
Ohta-ku, Tokyo
Pfizer Investigational Site
Osaka, Osaka
Pfizer Investigational Site
Shizuoka, Shizuoka
Pfizer Investigational Site
Sumida-ku, Tokyo
Pfizer Investigational Site
Susono, Shizuoka
Pfizer Investigational Site
Tachikawa, Tokyo
Pfizer Investigational Site
Taito-ku, Tokyo
Pfizer Investigational Site
Tokyo, Japan
Pfizer Investigational Site
Tokyo
Pfizer Investigational Site
Urayasu, Chiba
Pfizer Investigational Site
Yokohama, Kanagawa
Pfizer Investigational Site
Yokohama, Kangawa
South Korea6 sites
Pfizer Investigational Site
Gwangju, 501-757
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 136-705
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Seoul
About this study
Official title: A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- CP-690,550 Eye drops, CP-690,550 Eye drops-vehicle, Sodium Hyaluronate
- Keywords
- Dry eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-690,550 Eye dropsDrug
Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
CP-690,550 Eye dropsDrug
Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks
CP-690,550 Eye dropsDrug
Ophthalmic topical solution, high dose, dosed once/day, 8 weeks
CP-690,550 Eye drops-vehicleDrug
Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
Sodium HyaluronateDrug
Ophthalmic topical solution, dosed 6 times/day, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Not described Receives: Drug: CP-690,550 Eye drops |
| Treatment 2 | Experimental | Not described Receives: Drug: CP-690,550 Eye drops |
| Treatment 3 | Experimental | Not described Receives: Drug: CP-690,550 Eye drops |
| Treatment 4 | Placebo comparator | Not described Receives: Drug: CP-690,550 Eye drops-vehicle |
| Treatment 5 | Active comparator | Not described Receives: Drug: Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Baseline, Week 8
Secondary outcomes (20)
Changes in Corneal Staining Scores for Study Eye From Baseline
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2 and 4
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Measured: Week 1, 2, 4 and 8
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4 and 8
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4 and 8
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4 and 8
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Measured: Week 1, 2, 4 and 8
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Measured: Week 1, 2, 4 and 8
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4 and 8
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4].
Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Measured: Baseline, Week 1, 2, 4 and 8
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.
The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Measured: Week 1, 2, 4 and 8
Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining.
100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Measured: Week 8
Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Measured: Week 8
Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Measured: Week 8
Number of Participants With Ocular Adverse Events (AEs)by Severity
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: 8 weeks
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: 8 weeks
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe).
Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
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.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135511
- Sponsor's protocol ID
- A3921072
- Status last verified
- Mar 2013
- First submitted
- 1 Jun 2010
- Last updated
- 7 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01135511
- Acronym / sponsor ID
- A3921072
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Posted 7 May 2013
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 the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: CP-690,550 Eye drops |
| Treatment 2 | Experimental | Drug: CP-690,550 Eye drops |
| Treatment 3 | Experimental | Drug: CP-690,550 Eye drops |
| Treatment 4 | Placebo comparator | Drug: CP-690,550 Eye drops-vehicle |
| Treatment 5 | Active comparator | Drug: Sodium Hyaluronate |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjective symptoms of dry eye for at least 6 months
- Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)
Key exclusion criteria (3 listed)
- Women who are nursing, pregnant or planning pregnancy during the study
- Participation in other studies within 30 days of screening visit
- Ocular disorders that may confound interpretation of study results
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 |
|---|---|---|
| CP-690,550 Eye dropsOphthalmic topical solution, low dose, dosed once/day, 8 weeks | Drug | Treatment 1 |
| CP-690,550 Eye dropsOphthalmic topical solution, medium dose, dosed once/day, 8 weeks | Drug | Treatment 2 |
| CP-690,550 Eye dropsOphthalmic topical solution, high dose, dosed once/day, 8 weeks | Drug | Treatment 3 |
| CP-690,550 Eye drops-vehicleOphthalmic topical solution, vehicle, dosed once/day, 8 weeks | Drug | Treatment 4 |
| Sodium HyaluronateOphthalmic topical solution, dosed 6 times/day, 8 weeks | Drug | Treatment 5 |
Primary outcome
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Time frame: Baseline, Week 8
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
20 secondary outcomes
Changes in Corneal Staining Scores for Study Eye From Baseline
Time frame: Baseline, Week 1, 2 and 4
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Time frame: Week 1, 2, 4 and 8
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
Time frame: Baseline, Week 1, 2, 4 and 8
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
Time frame: Week 1, 2, 4 and 8
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
Time frame: Week 1, 2, 4 and 8
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
Time frame: Baseline, Week 1, 2, 4 and 8
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
Time frame: Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
Time frame: Baseline, Week 1, 2, 4 and 8
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
Time frame: Week 1, 2, 4 and 8
Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
Time frame: Week 8
Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
Time frame: Week 8
Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
Time frame: Week 8
Number of Participants With Ocular Adverse Events (AEs)by Severity
Time frame: 8 weeks
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Time frame: 8 weeks
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Dry Eye Syndromes
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.
Pfizer CT.gov Call Center study director
Pfizer
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-690,550 Eye drops and Sodium Hyaluronate in people with Dry Eye Syndromes, run by Pfizer at 28 sites in 2 countries.
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 2 inclusion and 3 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 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Japan, South Korea. 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 7 May 2013). 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?
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 (time frame: Baseline, Week 8). 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 7 May 2013.