Allergic ConjunctivitisPhase 2NCT02978183

Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis

A Phase 2 study testing ST266 and Saline (0.9% NaCl) in people with Allergic Conjunctivitis, run by Noveome Biotherapeutics, formerly Stemnion at 2 sites 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 purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to placebo for the treatment 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?: ST266 and Saline (0.9% NaCl)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 2 sitesUnited States
Study dates: Dec 2016to Nov 2017
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 at least 18 years of age of either gender and any race;
provide written informed consent and sign the HIPAA form;
be willing and able to follow all instructions and attend all study visits; have a positive history of ocular allergies and a positive skin test reaction to a seasonal AND perennial allergen as confirmed by an allergic skin test;
be able and willing to avoid all disallowed medication for the appropriate washout period and during the study;
be able and willing to discontinue wearing contact lenses for at least 72 hours prior to and during the study trial period;
(for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and at the study exit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration and for at least 14 days prior to instillation of investigational product). Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);

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have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
have a positive post-CAC reaction;
have a positive post-CAC reaction in two out of the first three time points;
be able to self-administer eye drops satisfactorily or have a caregiver at home routinely available for this purpose.

Who cannot join

have known contraindications or sensitivities to the use of the investigational product or any of its 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, or pterygium);
have had ocular surgical intervention within 3 months prior to initiating the study 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 active retinal disease;
have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit;
use any of the disallowed medications during the period indicated prior to and during the study;

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have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease [including arrhythmias]) the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens);
manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the screening visit;
have planned surgery (ocular or systemic) during the trial period or within 30 days after;
have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial;
be a female who is currently pregnant, planning a pregnancy, or lactating.
have cancer or have a history of cancer within the last 5 years.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
Andover, Massachusetts, 01810
Study site
Memphis, Tennessee, 38119

Other trials in United States

About this study

Official title: A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model

The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis.

Read the detailed description

The study is a multi-center, double-masked, randomized, placebo-controlled, modified conjunctival allergen challenge (CAC) model. The primary endpoints of ocular itching and conjunctival redness will be evaluated at the subject's final visit. Subjects who meet inclusion criteria will be randomized to one of two treatment groups (1:1). Randomization will be stratified by average post-CAC itching scores at baseline.

Subjects will be evaluated at baseline and on Days 6, 7 and 8.

Conditions: Allergic Conjunctivitis
Being tested: ST266, Saline (0.9% NaCl)
Medical subject headings: Conjunctivitis, Allergic

What participants receive

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

ST266Biological
One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
Saline (0.9% NaCl)Drug
One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.

Study groups in NCT02978183
Study group	Role	What they receive
Group 1	Active comparator	1X ST266 dosed 4 times a day for 8 days Receives: Biological: ST266
Group 2	Placebo comparator	Placebo dosed 4 times a day for 8 days Receives: Drug: Saline (0.9% NaCl)

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. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.
Measured: Day 7 and 8
Conjunctival Redness
Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness.
Measured: Day 7 and 8

Secondary outcomes (10)

Ciliary Redness
Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Measured: Day 7 and 8
Episcleral Redness
Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Measured: Day 7 and 8
Chemosis
Chemosis evaluated by the investigator. Chemosis was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less chemosis.
Measured: Day 7 and 8
Eyelid Swelling
Eyelid swelling evaluated by the subject. Eyelid swelling was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less swelling.
Measured: Day 7 and 8
Tearing/Watery Eyes
Tearing evaluated by the subject. Tearing was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less tearing.
Measured: Day 7 and 8
Rhinorrhea
Rhinorrhea evaluated by the subject. Rhinorrhea was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Measured: Day 7 and 8
Nasal Pruritus
Nasal Pruritus evaluated by the subject. Nasal pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Measured: Day 7 and 8
Ear or Palate Pruritus
Ear or palate pruritus evaluated by the subject. Ear or palate pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Measured: Day 7 and 8
Nasal Congestion
Nasal congestion evaluated by the subject. Nasal congestion was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Measured: Day 7 and 8
Nasal Composite Score
A composite score of presence or absence of at least one nasal symptom evaluated by the subject
Measured: Day 7 and 8

Timeline

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

Dec 2016Nov 2017

First posted30 Nov 2016 (estimated)
Study startDec 2016
Primary completionFeb 2017
Study completionNov 2017

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02978183
Sponsor's protocol ID: ST266-AC-201
Status last verified: Mar 2023
First submitted: 28 Nov 2016
Last updated: 10 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model
ClinicalTrials.gov ID: NCT02978183
Acronym / sponsor ID: ST266-AC-201
Conditions: Allergic Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Noveome Biotherapeutics, formerly StemnionIndustry (pharma, biotech, devices)
Study start: Dec 2016 (actual)
Primary completion: Feb 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 30 Nov 2016 (estimated)
Results: Posted 16 Sep 2021

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 the efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis.

Detailed description

Subjects will be evaluated at baseline and on Days 6, 7 and 8.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1	Active comparator	Biological: ST2661X ST266 dosed 4 times a day for 8 days
Group 2	Placebo comparator	Drug: Saline (0.9% NaCl)Placebo dosed 4 times a day for 8 days

Who may qualify

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

Key inclusion criteria (10 listed)

be at least 18 years of age of either gender and any race;
provide written informed consent and sign the HIPAA form;
be willing and able to follow all instructions and attend all study visits; have a positive history of ocular allergies and a positive skin test reaction to a seasonal AND perennial allergen as confirmed by an allergic skin test;
be able and willing to avoid all disallowed medication for the appropriate washout period and during the study;
be able and willing to discontinue wearing contact lenses for at least 72 hours prior to and during the study trial period;

Key exclusion criteria (12 listed)

have known contraindications or sensitivities to the use of the investigational product or any of its 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, or pterygium);
have had ocular surgical intervention within 3 months prior to initiating the study 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 active retinal disease;
have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit;

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
ST266One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.	Biological	Group 1
Saline (0.9% NaCl)One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.	Drug	Group 2

Primary outcome

Ocular Itching
Time frame: Day 7 and 8
Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.
Conjunctival Redness
Time frame: Day 7 and 8
Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness.

10 secondary outcomes

Ciliary Redness
Time frame: Day 7 and 8
Episcleral Redness
Time frame: Day 7 and 8
Chemosis
Time frame: Day 7 and 8
Eyelid Swelling
Time frame: Day 7 and 8
Tearing/Watery Eyes
Time frame: Day 7 and 8
Rhinorrhea
Time frame: Day 7 and 8
Nasal Pruritus
Time frame: Day 7 and 8
Ear or Palate Pruritus
Time frame: Day 7 and 8
Nasal Congestion
Time frame: Day 7 and 8
Nasal Composite Score
Time frame: Day 7 and 8

Results and safety

Results posted to the registry on 16 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	34	34
Group 2	36	36

Primary outcome: Ocular Itching

Time frame: Day 7 and 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Group 1 n = 34	Group 2 n = 36
Day 7, Pre-Conjunctival Allergen Challenge	0.508 (0.8373)	0.139 (0.3131)
Day 7, 5 Minutes Post Conjunctival Allergen Challenge	2.485 (0.9533)	2.535 (1.1070)
Day 7, 7 Minutes Post Conjunctival Allergen Challenge	2.559 (0.9887)	2.576 (1.1113)
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	2.434 (0.9320)	2.458 (1.1124)
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	2.154 (0.9415)	2.181 (1.1520)
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.838 (0.9960)	1.910 (1.1482)
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	1.529 (0.9103)	1.722 (1.1707)
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	1.346 (0.9435)	1.583 (1.1164)

Group 1 vs Group 2: p = 0.0882, ANCOVA
Group 1 vs Group 2: p = 0.8032, ANCOVA
Group 1 vs Group 2: p = 0.9003, ANCOVA

Population analysed: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B

Primary outcome: Conjunctival Redness

Time frame: Day 7 and 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Group 1 n = 34	Group 2 n = 36
Day 7, Pre-Conjunctival Allergen Challenge	1.103 (0.7541)	1.028 (0.5818)
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	2.125 (0.8817)	1.958 (0.8814)
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	1.897 (0.9714)	1.882 (0.9073)
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.926 (1.0308)	1.771 (0.8481)
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	1.875 (1.0005)	1.743 (0.8377)
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	1.816 (1.0323)	1.681 (0.8775)
Day 8, Pre-Conjunctival Allergen Challenge	0.912 (0.6682)	0.819 (0.4766)
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.963 (0.7909)	1.917 (0.7319)

Group 1 vs Group 2: p = 0.8165, ANCOVA
Group 1 vs Group 2: p = 0.6590, ANCOVA
Group 1 vs Group 2: p = 0.7455, ANCOVA

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed for subjects over a period of 8 days during active treatment. If an AE was unresolved at the final study visit Investigators were instructed to follow-up with subjects until the AE resolved or they were lost to follow-up. If the patient is lost to follow-up, the Investigator should make 3 reasonable attempts to contact the patient via telephone, post, or certified mail.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 34 (0%)	2 of 34 (5.9%)	0 of 34
Group 2	0 of 36 (0%)	3 of 36 (8.3%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Allergic Conjunctivitis

RecruitingPhase 3
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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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ST266 and Saline (0.9% NaCl) in people with Allergic Conjunctivitis, run by Noveome Biotherapeutics, formerly Stemnion at 2 sites 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 10 inclusion and 12 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 16 Sep 2021). 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: Day 7 and 8). 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 NCT02978183.

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 10 Apr 2023.