Allergic ConjunctivitisPhase 2NCT00882687

Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis

A Phase 2 study testing Lifitegrast in people with Allergic Conjunctivitis, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Lifitegrast
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2009to 10 May 2009
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

Signed informed consent form and HIPAA document
Willing and able to comply with all study procedures
Be at least 18 years of age at the time of enrollment
20/40 vision, or better, in each eye
History of ocular allergies, and a positive skin and ocular allergic reaction to allergens
A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Who cannot join

Preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, glaucoma, diabetic retinopathy, clinically significant blepharitis, follicular conjunctivitis and iritis)
Have had any ocular infection within the last 30 days
A positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears)
Any significant illness that could be expected to interfere with study parameters
Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye
Use of any investigational product or device within one month prior to Visit 1 or during the study period

Show all 11Show fewer

Concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial or within the washout period
Any blood donation or significant loss of blood within 56 days of Visit 1
Any history of autoimmune disease, immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant. Any known history of iritis/uveitis, glaucoma, or other chronic ophthalmologic disorder other than allergic conjunctivitis
History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 3 months prior to Visit 1
Known history of alcohol abuse and/or drug abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

Ora
Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: A Phase 2, Single Center, Randomized, Double-Masked and Placebo Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1, 1.0, 5.0%) of SAR 1118 Ophthalmic Solution in a Modified Conjunctival Allergen Challenge (CAC) Model

The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis

Conditions: Allergic Conjunctivitis
Being tested: Lifitegrast, Placebo
Medical subject headings: Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LifitegrastDrug
Also called SAR 1118
Ophthalmic Solution
PlaceboOther
Ophthalmic Solution

Study groups in NCT00882687
Study group	Role	What they receive
0.1% Lifitegrast	Experimental	Not described Receives: Drug: Lifitegrast
1.0% Lifitegrast	Experimental	Not described Receives: Drug: Lifitegrast
5.0% Lifitegrast	Experimental	Not described Receives: Drug: Lifitegrast
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6])
Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching. CAC is an initial titration challenge to determine the appropriate allergen and lowest concentration of allergen that produced a positive bilateral allergic response for each subject, defined as ≥ 2 score (0-4 point scale) in ocular itching and conjunctival redness within 10 minutes of the last titration of allergen.
Measured: Baseline to Day 7 (7 minutes post CAC 6)
Ocular Itching at Day 14 (7 Minutes Post CAC 9)
Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.
Measured: Baseline to Day 14 (7 minutes post CAC 9)
Conjunctival Redness at Day 7 (20 Minutes Post CAC 6)
Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.
Measured: Baseline to Day 7 (20 minutes post CAC 6)
Conjunctival Redness at Day 14 (20 Minutes Post CAC 9)
Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.
Measured: Baseline to Day 14 (20 minutes post CAC 9)

Secondary outcomes (2)

Ocular Itching at Day 6 (CAC 4), 5 (CAC 7)
Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.
Measured: Baseline to Day 6 (CAC 4), Day 13 (CAC 7) 7 minutes post CAC
Conjunctival Redness at Day 6 (CAC 4), 5 (CAC 7)
Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.
Measured: Baseline to Day 6 (CAC 4), Day 13 (CAC 7) at 20 minutes post CAC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 200910 May 2009

First posted16 Apr 2009 (estimated)
Study start24 Apr 2009
Primary completion10 May 2009
Study completion10 May 2009

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 Allergic ConjunctivitisStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00882687
Sponsor's protocol ID: 1118-ACJ-100
Status last verified: Jun 2021
First submitted: 15 Apr 2009
Last updated: 11 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Single Center, Randomized, Double-Masked and Placebo Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1, 1.0, 5.0%) of SAR 1118 Ophthalmic Solution in a Modified Conjunctival Allergen Challenge (CAC) Model
ClinicalTrials.gov ID: NCT00882687
Acronym / sponsor ID: 1118-ACJ-100
Conditions: Allergic Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 24 Apr 2009 (actual)
Primary completion: 10 May 2009 (actual)
Study completion: 10 May 2009 (actual)
First posted: 16 Apr 2009 (estimated)
Results: Posted 24 Feb 2017

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 whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
0.1% Lifitegrast	Experimental	Drug: Lifitegrast
1.0% Lifitegrast	Experimental	Drug: Lifitegrast
5.0% Lifitegrast	Experimental	Drug: Lifitegrast
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed informed consent form and HIPAA document
Willing and able to comply with all study procedures
Be at least 18 years of age at the time of enrollment
20/40 vision, or better, in each eye
History of ocular allergies, and a positive skin and ocular allergic reaction to allergens

Key exclusion criteria (11 listed)

Preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, glaucoma, diabetic retinopathy, clinically significant blepharitis, follicular conjunctivitis and iritis)
Have had any ocular infection within the last 30 days
A positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears)
Any significant illness that could be expected to interfere with study parameters
Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye

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
LifitegrastAlso: SAR 1118Ophthalmic Solution	Drug	0.1% Lifitegrast, 1.0% Lifitegrast, 5.0% Lifitegrast
PlaceboOphthalmic Solution	Other	Placebo

Primary outcome

Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6])
Time frame: Baseline to Day 7 (7 minutes post CAC 6)
Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching. CAC is an initial titration challenge to determine the appropriate allergen and lowest concentration of allergen that produced a positive bilateral allergic response for each subject, defined as ≥ 2 score (0-4 point scale) in ocular itching and conjunctival redness within 10 minutes of the last titration of allergen.
Ocular Itching at Day 14 (7 Minutes Post CAC 9)
Time frame: Baseline to Day 14 (7 minutes post CAC 9)
Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.
Conjunctival Redness at Day 7 (20 Minutes Post CAC 6)
Time frame: Baseline to Day 7 (20 minutes post CAC 6)
Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.
Conjunctival Redness at Day 14 (20 Minutes Post CAC 9)
Time frame: Baseline to Day 14 (20 minutes post CAC 9)
Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.

2 secondary outcomes

Ocular Itching at Day 6 (CAC 4), 5 (CAC 7)
Time frame: Baseline to Day 6 (CAC 4), Day 13 (CAC 7) 7 minutes post CAC
Conjunctival Redness at Day 6 (CAC 4), 5 (CAC 7)
Time frame: Baseline to Day 6 (CAC 4), Day 13 (CAC 7) at 20 minutes post CAC

Results and safety

Results posted to the registry on 24 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lifitegrast 0.1%	15	13
Lifitegrast 1.0%	15	13
Lifitegrast 5.0%	15	12
Placebo	15	13

Primary outcome: Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6])

Time frame: Baseline to Day 7 (7 minutes post CAC 6). Mean (Standard Deviation). Unit: units on a scale

Measure	Lifitegrast 0.1% n = 15	Lifitegrast 1.0% n = 15	Lifitegrast 5.0% n = 15	Placebo n = 15
Value	2.65 (0.731)	2.68 (1.096)	3.07 (0.837)	2.88 (0.410)

Lifitegrast 0.1% vs Placebo: p = 0.3235, Wilcoxon rank-sum test
Lifitegrast 1.0% vs Placebo: p = 0.9144, Wilcoxon rank-sum test
Lifitegrast 5.0% vs Placebo: p = 0.3324, Wilcoxon rank-sum test

Population analysed: Intent-to-treat (ITT) population with last observation carried forward (LOCF)

Primary outcome: Ocular Itching at Day 14 (7 Minutes Post CAC 9)

Time frame: Baseline to Day 14 (7 minutes post CAC 9). Mean (Standard Deviation). Unit: units on a scale

Measure	Lifitegrast 0.1% n = 15	Lifitegrast 1.0% n = 15	Lifitegrast 5.0% n = 15	Placebo n = 15
Value	2.28 (1.043)	2.50 (1.191)	2.63 (0.968)	2.12 (0.737)

Lifitegrast 0.1% vs Placebo: p = 0.5846, Wilcoxon rank-sum test
Lifitegrast 1.0% vs Placebo: p = 0.1493, Wilcoxon rank-sum test
Lifitegrast 5.0% vs Placebo: p = 0.0404, Wilcoxon rank-sum test

Population analysed: ITT population with LOCF

Primary outcome: Conjunctival Redness at Day 7 (20 Minutes Post CAC 6)

Time frame: Baseline to Day 7 (20 minutes post CAC 6). Mean (Standard Deviation). Unit: units on a scale

Measure	Lifitegrast 0.1% n = 15	Lifitegrast 1.0% n = 15	Lifitegrast 5.0% n = 15	Placebo n = 15
Value	2.27 (0.458)	2.48 (0.406)	2.57 (0.477)	2.52 (0.427)

Lifitegrast 0.1% vs Placebo: p = 0.0578, Wilcoxon rank-sum test
Lifitegrast 1.0% vs Placebo: p = 0.8988, Wilcoxon rank-sum test
Lifitegrast 5.0% vs Placebo: p = 0.4709, Wilcoxon rank-sum test

Population analysed: ITT population with LOCF

Primary outcome: Conjunctival Redness at Day 14 (20 Minutes Post CAC 9)

Time frame: Baseline to Day 14 (20 minutes post CAC 9). Mean (Standard Deviation). Unit: units on a scale

Measure	Lifitegrast 0.1% n = 15	Lifitegrast 1.0% n = 15	Lifitegrast 5.0% n = 15	Placebo n = 15
Value	1.92 (0.686)	2.42 (0.397)	2.38 (0.399)	2.17 (0.652)

Lifitegrast 0.1% vs Placebo: p = 0.1773, Wilcoxon rank-sum test
Lifitegrast 1.0% vs Placebo: p = 0.4222, Wilcoxon rank-sum test
Lifitegrast 5.0% vs Placebo: p = 0.4326, Wilcoxon rank-sum test

Population analysed: ITT population with LOCF

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lifitegrast 0.1%	0 of 15 (0%)	6 of 15 (40%)	Not reported
Lifitegrast 1.0%	0 of 15 (0%)	7 of 15 (46.7%)	Not reported
Lifitegrast 5.0%	0 of 15 (0%)	12 of 15 (80%)	Not reported
Placebo	1 of 15 (6.7%)	6 of 15 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Study Director study director

Takeda

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 Lifitegrast in people with Allergic Conjunctivitis, run by Shire 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 6 inclusion and 11 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 11 Jun 2021. 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 24 Feb 2017). 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?

Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6]) (time frame: Baseline to Day 7 (7 minutes post CAC 6)). The study lists 4 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 NCT00882687.

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 11 Jun 2021.