Allergic ConjunctivitisPhase 2NCT01320553

Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis

A Phase 2 study testing SPARC1102 I, SPARC1102 II and SPARC1102 III in people with Allergic Conjunctivitis, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.

Completed

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

Official record

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Trial summary

The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older. Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: SPARC1102 I, SPARC1102 II and SPARC1102 III
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Sep 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 10 years and older
All sexes
No healthy volunteers
Child, 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 10 years of age at the time of enrollment
LogMar 0.7 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

have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye);
have a current diagnosis or history of open angle glaucoma or ocular hypertension;
have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 6 months;
have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;
have the presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit;
manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at screening or during study
have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

ORA Inc
Andover, Massachusetts, 01810

Other trials in United States

About this study

The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older.

Conditions: Allergic Conjunctivitis
Being tested: SPARC1102 I, SPARC1102 II, SPARC1102 III, Vehicle
Medical subject headings: Conjunctivitis, Allergic

What participants receive

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

SPARC1102 IDrug
SPARC1102 I will be administered in both eyes
SPARC1102 IIDrug
SPARC1102 II will be administered in both eyes
SPARC1102 IIIDrug
SPARC1102 III will be administered in both eyes
VehicleDrug
Vehicle will be administered in both eyes

Study groups in NCT01320553
Study group	Role	What they receive
SPARC1102 I	Experimental	1334H 0.15% eye drops will be administered in both eyes at 3 occasions Receives: Drug: SPARC1102 I
SPARC1102 II	Experimental	1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions Receives: Drug: SPARC1102 II
SPARC1102 III	Experimental	1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions Receives: Drug: SPARC1102 III
Vehicle	Placebo comparator	Placebo eye drops (solution)will be administered in both eyes at 3 occasions Receives: Drug: Vehicle

What is being measured

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

Ocular Itching
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5.
Measured: Up to 28 days

Secondary outcomes (1)

Ciliary Redness Evaluated by the Investigator
Ciliary redness and episcleral redness were evaluated by the investigator at 7, 15, and 20 minutes post-CAC using a 4-point (0 indicating none and 4 indicating extremely severe i.e. large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) scale with half-unit (1-step) increments allowed.
Measured: Up to 4 weeks

Timeline

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

Jun 2011Sep 2011

First posted22 Mar 2011 (estimated)
Study startJun 2011
Primary completionAug 2011
Study completionSep 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 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01320553
Sponsor's protocol ID: CLR_11_02
Status last verified: May 2016
First submitted: 18 Mar 2011
Last updated: 24 Jun 2016
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 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
ClinicalTrials.gov ID: NCT01320553
Acronym / sponsor ID: CLR_11_02
Conditions: Allergic Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Aug 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 22 Mar 2011 (estimated)
Results: Posted 20 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
SPARC1102 I	Experimental	Drug: SPARC1102 I1334H 0.15% eye drops will be administered in both eyes at 3 occasions
SPARC1102 II	Experimental	Drug: SPARC1102 II1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions
SPARC1102 III	Experimental	Drug: SPARC1102 III1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions
Vehicle	Placebo comparator	Drug: VehiclePlacebo eye drops (solution)will be administered in both eyes at 3 occasions

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, 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 10 years of age at the time of enrollment
LogMar 0.7 or better, in each eye
History of ocular allergies, and a positive skin and ocular allergic reaction to allergens

Key exclusion criteria (8 listed)

have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye);
have a current diagnosis or history of open angle glaucoma or ocular hypertension;
have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 6 months;
have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;

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
SPARC1102 ISPARC1102 I will be administered in both eyes	Drug	SPARC1102 I
SPARC1102 IISPARC1102 II will be administered in both eyes	Drug	SPARC1102 II
SPARC1102 IIISPARC1102 III will be administered in both eyes	Drug	SPARC1102 III
VehicleVehicle will be administered in both eyes	Drug	Vehicle

Primary outcome

Ocular Itching
Time frame: Up to 28 days
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5.

1 secondary outcome

Ciliary Redness Evaluated by the Investigator
Time frame: Up to 4 weeks

Results and safety

Results posted to the registry on 20 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1334 H 0.15%	31	30
1334 H-0.3%	30	26
1334 H-0.45%	31	29
Vehicle	30	29

Primary outcome: Ocular Itching

Time frame: Up to 28 days. Mean (Standard Deviation). Unit: units on a scale

Measure	1334 H 0.15% n = 29	1334 H-0.3% n = 24	1334 H-0.45% n = 26	Vehicle n = 28
7 minutes post challenge	1.27 (1.085)	1.57 (1.174)	1.16 (1.125)	1.88 (0.854)
5 minutes post challenge	1.34 (1.068)	1.40 (1.108)	1.23 (1.109)	2.12 (0.854)
3 minutes post challenge	0.92 (0.989)	1.01 (0.931)	0.86 (0.889)	2.06 (0.912)

Population analysed: Of the 122 subjects enrolled in the study, a total of 8 subjects did not complete the study: 1 in the 1334H 0.15% group, 4 in the 1334H 0.3% group, 2 in the 1334H 0.45% group and 1 in the vehicle treated group. The Per Protocol population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1334 H 0.15%	0 of 31 (0%)	6 of 31 (19.4%)	Not reported
1334 H-0.3%	1 of 30 (3.3%)	6 of 30 (20%)	Not reported
1334 H-0.45%	0 of 31 (0%)	12 of 31 (38.7%)	Not reported
Vehicle	0 of 30 (0%)	11 of 30 (36.7%)	Not reported

Limitations and caveats (from the sponsor): Of the total of 122 subjects, 8 subjects did not complete the study: 114 subjects completed the study, PP population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Conjunctivitis

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
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RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 SPARC1102 I, SPARC1102 II and SPARC1102 III in people with Allergic Conjunctivitis, run by Sun Pharma Advanced Research Company Limited 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 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 24 Jun 2016. 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 20 May 2016). 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 (time frame: Up to 28 days). 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 NCT01320553.

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 24 Jun 2016.