Conjunctivitis, AllergicPhase 4NCT03186755
Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis
A Phase 4 study testing Hyaluronic acid 0.05% & Ectoine 2.0% and Olopatadine hydrochloride ophthalmic solution 0.1% in people with Conjunctivitis, Allergic and Conjunctivitis, Vernal, run by Michael Marchand, MD at 1 site in Canada.
Trial summary
This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% \& Ectoine 2.0%) and Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal allergic conjunctivitis in the pediatric population. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Conjunctivitis, Allergic, Conjunctivitis, Vernal
- What is being tested?
- Hyaluronic acid 0.05% & Ectoine 2.0% and Olopatadine hydrochloride ophthalmic solution 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jun 2017to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children of either sex and any race aged 6 to 18 years
- History of seasonal allergic conjunctivitis lasting at least 1 allergy season (including patients with rhinoconjunctivitis and atopic dermatitis)
- Current complaint of itching and conjunctival redness in both eyes
- Positive skin reaction to at least one common local grass pollen, including Gramineae, at screening or in the 12 months before the study
Who cannot join
- Another previous or ongoing ocular disorder
- Presence of significant corneal involvement
- Sensitivity to any component of the study medications
- Use of medication between 1 week before the study and study completion that could confound the interpretation of results (i.e. antihistamines, corticosteroids, nonsteroidal anti-inflammatory drugs, mast cell stabilizers, topical ocular vasoconstrictors)
- Participation in other pharmacologic studies during the month before the study
- Poor baseline visual acuity (not correctable to ≥ 0.6 logMAR in both eyes)
Show all 9Show fewer
- Autoimmune disease associated with dry eye syndrome (eg, rheumatoid arthritis)
- Inability to discontinue wearing contact lenses during the study
- Inability to discontinue the use of concomitant medication: immunosuppressive drugs, sulfa- or neomycin-containing antibiotics, antibiotics causing allergic reaction
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine Hospital
Montreal, Quebec, H3T 1C5
Michael Marchand, MD, 514-805-1247, mic9@sympatico.ca
Emilie Goodyear, MD
About this study
Official title: Randomized Controlled Trial Comparing Olopatadine 0.1% Ophthalmic Solution With Hylo-Dual Ophthalmic Preparation in Children With Seasonal Allergic Conjunctivitis
This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% \& Ectoine 2.0%) and Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal allergic conjunctivitis in the pediatric population. Half of participants will receive Hylo-Dual, while the other half will receive Olopatadine treatment for 2 months.
Read the detailed description
Seasonal allergic conjunctivitis (SAC) is an inflammatory response of the conjunctiva triggered by exposure to seasonal allergens. SAC is the most common form of ocular allergy, with an estimated prevalence of approximately 15 to 20%. The distressing signs (redness, chemosis, eyelid swelling) and symptoms (itching, tearing, redness) of SAC may cause extreme discomfort, with a burden due to the frequency and duration of the disease more than to its seriousness.
Olopatadine hydrochloride ophthalmic solution 0.1% is a topical antiallergic agent that is both an antihistamine with high affinity and selectivity for the histamine H1 receptor and a mast cell stabilizer that inhibits the release of histamine and other proinflammatory mediators from human conjunctival mast cells. The efficacy and tolerability of olopatadine has been demonstrated by several comparative studies in adults and children with seasonal allergic conjunctivitis.
Hylo-Dual eye drops is an approved treatment in Canada for children 6 years and older, containing 0.5mg/ml Sodium Hyaluronate, 20mg/ml Ectoine, a borate buffer and water. Ectoine is a natural substance formed by microorganisms to protect themselves from extreme environments (e.g.: salt lakes or hot geysers). They adapt to these conditions by so-called extremolytes, like ectoine, which are osmoprotective substances stabilizing biological membranes. Ectoine has a strong water-binding capacity, forming a physiologic barrier protecting cell membranes from contact with allergenic substances and against inflammatory responses to environmental stress (such as dehydration, e.g. by hyperosmolar tears, UV radiation or airborne allergens). Additionally, ectoine has a stabilizing effect on the lipid phase of the tear film by increasing its elasticity, which causes it to spread evenly over the eye surface and protects against the excessive evaporation of tears.
To the knowledge of the investigators, no systematic interventional prospective study exists comparing the efficacy of Olopatadine and Hylo-Dual for the treatment of seasonal allergic conjunctivitis in the pediatric population. The research question is to determine if both treatment options are equally effective in this population, therefore providing further clinical pharmacologic data relevant to children.
- Conditions
- Conjunctivitis, Allergic, Conjunctivitis, Vernal
- Being tested
- Hyaluronic acid 0.05% & Ectoine 2.0%, Olopatadine hydrochloride ophthalmic solution 0.1%
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid 0.05% & Ectoine 2.0%Drug
Also called Hylo-Dual
Treatment of 1 drop three times a day in both eyes for 8 weeks
Olopatadine hydrochloride ophthalmic solution 0.1%Drug
Also called Patanol
Treatment of 1 drop two times a day in both eyes for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hylo-Dual | Experimental | Hyaluronic acid 0.05% \& Ectoine 2.0% (Hylo-Dual) 1 drop in both eyes 3 times/day for 8 weeks Receives: Drug: Hyaluronic acid 0.05% & Ectoine 2.0% |
| Patanol | Active comparator | Olopatadine hydrochloride ophthalmic solution 0.1% (Olopatadine) 1 drop in both eyes 2 times/day for 8 weeks Receives: Drug: Olopatadine hydrochloride ophthalmic solution 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of conjunctival erythema
Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement). Scale based on the Efron scale.
Measured: 56 days
Secondary outcomes (7)
Signs of conjunctival erythema
Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement). Scale based on the Efron scale.
Measured: 7 days, 14 days, 30 days, 42 days
Signs of conjunctival chemosis
Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement).
Measured: 7 days, 14 days, 30 days, 42 days, 56 days
Signs of eyelid swelling
Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement).
Measured: 7 days, 14 days, 30 days, 42 days, 56 days
Symptoms of itching, self-rated
Response to the question, "How often during the last 3 days did your eyes itch enough that you wanted to rub them?" Rated on a 5-point scale.
Measured: 7 days, 14 days, 30 days, 42 days, 56 days
Symptoms of redness, self-rated
Rated by patient or parents on an 11-point scale (VAS - Visual Analog Scale) where 0 = no redness and 10 = the most intense redness imaginable.
Measured: 7 days, 14 days, 30 days, 42 days, 56 days
Physician's Impression Scale ratings (change scores)
Rated on a 6-point scale: 0 = clinical cure, 1 = satisfactory clinical response, 2 = slight clinical improvement, 3 = clinically unchanged, 4 = slightly clinically worse, and 5 = significantly clinically worse.
Measured: 7 days, 14 days, 30 days, 42 days, 56 days
Listing of adverse effects potentially related to the ophthalmic treatment
Based on visual acuity, pupil diameter, intraocular pressure, slit-lamp examination and a dilated fundus examination by an ophthalmologist.
Measured: 7 days, 14 days, 30 days, 42 days, 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start11 Jun 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Conjunctivitis, AllergicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Monocentric, Randomized Controlled Trial, Parallel-group, Single-masked for assessors
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Marchand, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Sponsor-investigator, Michael Marchand, MD, St. Justine's Hospital
- Investigators
- Emilie Goodyear, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186755
- Sponsor's protocol ID
- 2017-1431
- Status last verified
- Oct 2022
- First submitted
- 11 Jun 2017
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leonardi A. Emerging drugs for ocular allergy. Expert Opin Emerg Drugs. 2005 Aug;10(3):505-20. doi: 10.1517/14728214.10.3.505.
PubMed 16083326Leonardi A. Pathophysiology of allergic conjunctivitis. Acta Ophthalmol Scand Suppl. 1999;(228):21-3. doi: 10.1111/j.1600-0420.1999.tb01167.x. No abstract available.
PubMed 10337426Mortemousque B, Bourcier T, Khairallah M, Messaoud R, Brignole-Baudouin F, Renault D, Rebika H, Bremond-Gignac D; Ketotifen Study Group. Comparison of preservative-free ketotifen fumarate and preserved olopatadine hydrochloride eye drops in the treatment of moderate to severe seasonal allergic conjunctivitis. J Fr Ophtalmol. 2014 Jan;37(1):1-8. doi: 10.1016/j.jfo.2013.02.007. Epub 2013 Dec 31.
PubMed 24388379Ciprandi G, Turner D, Gross RD. Double-masked, randomized, parallel-group study comparing olopatadine 0.1% ophthalmic solution with cromolyn sodium 2% and levocabastine 0.05% ophthalmic preparations in children with seasonal allergic conjunctivitis. Curr Ther Res Clin Exp. 2004 Mar;65(2):186-99. doi: 10.1016/S0011-393X(04)90032-X.
PubMed 24764588Bielory L. Update on ocular allergy treatment. Expert Opin Pharmacother. 2002 May;3(5):541-53. doi: 10.1517/14656566.3.5.541.
PubMed 11996633Bielory L, Lien KW, Bigelsen S. Efficacy and tolerability of newer antihistamines in the treatment of allergic conjunctivitis. Drugs. 2005;65(2):215-28. doi: 10.2165/00003495-200565020-00004.
PubMed 15631542Katelaris CH, Ciprandi G, Missotten L, Turner FD, Bertin D, Berdeaux G; International Olopatadine Study Group. A comparison of the efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and cromolyn sodium 2% ophthalmic solution in seasonal allergic conjunctivitis. Clin Ther. 2002 Oct;24(10):1561-75. doi: 10.1016/s0149-2918(02)80060-1.
PubMed 12462286McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.
PubMed 26266427Torkildsen G, Narvekar A, Bergmann M. Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model. Clin Ophthalmol. 2015 Sep 14;9:1703-13. doi: 10.2147/OPTH.S83263. eCollection 2015.
PubMed 26392751Kam KW, Chen LJ, Wat N, Young AL. Topical Olopatadine in the Treatment of Allergic Conjunctivitis: A Systematic Review and Meta-analysis. Ocul Immunol Inflamm. 2017 Oct;25(5):663-677. doi: 10.3109/09273948.2016.1158282. Epub 2016 May 18.
PubMed 27192186Bestvater T, Louis P, Galinski EA. Heterologous ectoine production in Escherichia coli: by-passing the metabolic bottle-neck. Saline Syst. 2008 Aug 29;4:12. doi: 10.1186/1746-1448-4-12.
PubMed 18759971Banciu HL, Sorokin DY, Tourova TP, Galinski EA, Muntyan MS, Kuenen JG, Muyzer G. Influence of salts and pH on growth and activity of a novel facultatively alkaliphilic, extremely salt-tolerant, obligately chemolithoautotrophic sufur-oxidizing Gammaproteobacterium Thioalkalibacter halophilus gen. nov., sp. nov. from South-Western Siberian soda lakes. Extremophiles. 2008 May;12(3):391-404. doi: 10.1007/s00792-008-0142-1. Epub 2008 Feb 29.
PubMed 18309455Beblo-Vranesevic K, Galinski EA, Rachel R, Huber H, Rettberg P. Influence of osmotic stress on desiccation and irradiation tolerance of (hyper)-thermophilic microorganisms. Arch Microbiol. 2017 Jan;199(1):17-28. doi: 10.1007/s00203-016-1269-6. Epub 2016 Jul 21.
PubMed 27443666Harishchandra RK, Wulff S, Lentzen G, Neuhaus T, Galla HJ. The effect of compatible solute ectoines on the structural organization of lipid monolayer and bilayer membranes. Biophys Chem. 2010 Aug;150(1-3):37-46. doi: 10.1016/j.bpc.2010.02.007. Epub 2010 Feb 11.
PubMed 20206435Dwivedi M, Brinkkotter M, Harishchandra RK, Galla HJ. Biophysical investigations of the structure and function of the tear fluid lipid layers and the effect of ectoine. Part B: artificial lipid films. Biochim Biophys Acta. 2014 Oct;1838(10):2716-27. doi: 10.1016/j.bbamem.2014.05.007. Epub 2014 May 20.
PubMed 24853656
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Olopatadine 0.1% Ophthalmic Solution With Hylo-Dual Ophthalmic Preparation in Children With Seasonal Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT03186755
- Acronym / sponsor ID
- 2017-1431
- Conditions
- Conjunctivitis, Allergic, Conjunctivitis, Vernal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Michael Marchand, MDUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 11 Jun 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% \& Ectoine 2.0%) and Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal allergic conjunctivitis in the pediatric population. Half of participants will receive Hylo-Dual, while the other half will receive Olopatadine treatment for 2 months.
Detailed description
Seasonal allergic conjunctivitis (SAC) is an inflammatory response of the conjunctiva triggered by exposure to seasonal allergens. SAC is the most common form of ocular allergy, with an estimated prevalence of approximately 15 to 20%. The distressing signs (redness, chemosis, eyelid swelling) and symptoms (itching, tearing, redness) of SAC may cause extreme discomfort, with a burden due to the frequency and duration of the disease more than to its seriousness.
Olopatadine hydrochloride ophthalmic solution 0.1% is a topical antiallergic agent that is both an antihistamine with high affinity and selectivity for the histamine H1 receptor and a mast cell stabilizer that inhibits the release of histamine and other proinflammatory mediators from human conjunctival mast cells. The efficacy and tolerability of olopatadine has been demonstrated by several comparative studies in adults and children with seasonal allergic conjunctivitis.
Hylo-Dual eye drops is an approved treatment in Canada for children 6 years and older, containing 0.5mg/ml Sodium Hyaluronate, 20mg/ml Ectoine, a borate buffer and water. Ectoine is a natural substance formed by microorganisms to protect themselves from extreme environments (e.g.: salt lakes or hot geysers). They adapt to these conditions by so-called extremolytes, like ectoine, which are osmoprotective substances stabilizing biological membranes. Ectoine has a strong water-binding capacity, forming a physiologic barrier protecting cell membranes from contact with allergenic substances and against inflammatory responses to environmental stress (such as dehydration, e.g. by hyperosmolar tears, UV radiation or airborne allergens). Additionally, ectoine has a stabilizing effect on the lipid phase of the tear film by increasing its elasticity, which causes it to spread evenly over the eye surface and protects against the excessive evaporation of tears.
To the knowledge of the investigators, no systematic interventional prospective study exists comparing the efficacy of Olopatadine and Hylo-Dual for the treatment of seasonal allergic conjunctivitis in the pediatric population. The research question is to determine if both treatment options are equally effective in this population, therefore providing further clinical pharmacologic data relevant to children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Monocentric, Randomized Controlled Trial, Parallel-group, Single-masked for assessors
| Arm | Type | Receives |
|---|---|---|
| Hylo-Dual | Experimental | Drug: Hyaluronic acid 0.05% & Ectoine 2.0%Hyaluronic acid 0.05% \& Ectoine 2.0% (Hylo-Dual) 1 drop in both eyes 3 times/day for 8 weeks |
| Patanol | Active comparator | Drug: Olopatadine hydrochloride ophthalmic solution 0.1%Olopatadine hydrochloride ophthalmic solution 0.1% (Olopatadine) 1 drop in both eyes 2 times/day for 8 weeks |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children of either sex and any race aged 6 to 18 years
- History of seasonal allergic conjunctivitis lasting at least 1 allergy season (including patients with rhinoconjunctivitis and atopic dermatitis)
- Current complaint of itching and conjunctival redness in both eyes
- Positive skin reaction to at least one common local grass pollen, including Gramineae, at screening or in the 12 months before the study
Key exclusion criteria (9 listed)
- Another previous or ongoing ocular disorder
- Presence of significant corneal involvement
- Sensitivity to any component of the study medications
- Use of medication between 1 week before the study and study completion that could confound the interpretation of results (i.e. antihistamines, corticosteroids, nonsteroidal anti-inflammatory drugs, mast cell stabilizers, topical ocular vasoconstrictors)
- Participation in other pharmacologic studies during the month before the study
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 |
|---|---|---|
| Hyaluronic acid 0.05% & Ectoine 2.0%Also: Hylo-DualTreatment of 1 drop three times a day in both eyes for 8 weeks | Drug | Hylo-Dual |
| Olopatadine hydrochloride ophthalmic solution 0.1%Also: PatanolTreatment of 1 drop two times a day in both eyes for 8 weeks | Drug | Patanol |
Primary outcome
Signs of conjunctival erythema
Time frame: 56 days
Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement). Scale based on the Efron scale.
7 secondary outcomes
Signs of conjunctival erythema
Time frame: 7 days, 14 days, 30 days, 42 days
Signs of conjunctival chemosis
Time frame: 7 days, 14 days, 30 days, 42 days, 56 days
Signs of eyelid swelling
Time frame: 7 days, 14 days, 30 days, 42 days, 56 days
Symptoms of itching, self-rated
Time frame: 7 days, 14 days, 30 days, 42 days, 56 days
Symptoms of redness, self-rated
Time frame: 7 days, 14 days, 30 days, 42 days, 56 days
Physician's Impression Scale ratings (change scores)
Time frame: 7 days, 14 days, 30 days, 42 days, 56 days
Listing of adverse effects potentially related to the ophthalmic treatment
Time frame: 7 days, 14 days, 30 days, 42 days, 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 16083326Leonardi A. Emerging drugs for ocular allergy. Expert Opin Emerg Drugs. 2005 Aug;10(3):505-20. doi: 10.1517/14728214.10.3.505.
- Background: PubMed 10337426Leonardi A. Pathophysiology of allergic conjunctivitis. Acta Ophthalmol Scand Suppl. 1999;(228):21-3. doi: 10.1111/j.1600-0420.1999.tb01167.x. No abstract available.
- Background: PubMed 24388379Mortemousque B, Bourcier T, Khairallah M, Messaoud R, Brignole-Baudouin F, Renault D, Rebika H, Bremond-Gignac D; Ketotifen Study Group. Comparison of preservative-free ketotifen fumarate and preserved olopatadine hydrochloride eye drops in the treatment of moderate to severe seasonal allergic conjunctivitis. J Fr Ophtalmol. 2014 Jan;37(1):1-8. doi: 10.1016/j.jfo.2013.02.007. Epub 2013 Dec 31.
- Background: PubMed 24764588Ciprandi G, Turner D, Gross RD. Double-masked, randomized, parallel-group study comparing olopatadine 0.1% ophthalmic solution with cromolyn sodium 2% and levocabastine 0.05% ophthalmic preparations in children with seasonal allergic conjunctivitis. Curr Ther Res Clin Exp. 2004 Mar;65(2):186-99. doi: 10.1016/S0011-393X(04)90032-X.
- Background: PubMed 11996633Bielory L. Update on ocular allergy treatment. Expert Opin Pharmacother. 2002 May;3(5):541-53. doi: 10.1517/14656566.3.5.541.
- Background: PubMed 15631542Bielory L, Lien KW, Bigelsen S. Efficacy and tolerability of newer antihistamines in the treatment of allergic conjunctivitis. Drugs. 2005;65(2):215-28. doi: 10.2165/00003495-200565020-00004.
- Background: PubMed 12462286Katelaris CH, Ciprandi G, Missotten L, Turner FD, Bertin D, Berdeaux G; International Olopatadine Study Group. A comparison of the efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and cromolyn sodium 2% ophthalmic solution in seasonal allergic conjunctivitis. Clin Ther. 2002 Oct;24(10):1561-75. doi: 10.1016/s0149-2918(02)80060-1.
- Background: PubMed 26266427McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.
- Background: PubMed 26392751Torkildsen G, Narvekar A, Bergmann M. Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model. Clin Ophthalmol. 2015 Sep 14;9:1703-13. doi: 10.2147/OPTH.S83263. eCollection 2015.
- Background: PubMed 27192186Kam KW, Chen LJ, Wat N, Young AL. Topical Olopatadine in the Treatment of Allergic Conjunctivitis: A Systematic Review and Meta-analysis. Ocul Immunol Inflamm. 2017 Oct;25(5):663-677. doi: 10.3109/09273948.2016.1158282. Epub 2016 May 18.
- Background: PubMed 18759971Bestvater T, Louis P, Galinski EA. Heterologous ectoine production in Escherichia coli: by-passing the metabolic bottle-neck. Saline Syst. 2008 Aug 29;4:12. doi: 10.1186/1746-1448-4-12.
- Background: PubMed 18309455Banciu HL, Sorokin DY, Tourova TP, Galinski EA, Muntyan MS, Kuenen JG, Muyzer G. Influence of salts and pH on growth and activity of a novel facultatively alkaliphilic, extremely salt-tolerant, obligately chemolithoautotrophic sufur-oxidizing Gammaproteobacterium Thioalkalibacter halophilus gen. nov., sp. nov. from South-Western Siberian soda lakes. Extremophiles. 2008 May;12(3):391-404. doi: 10.1007/s00792-008-0142-1. Epub 2008 Feb 29.
- Individual participant dataSharing planned: No
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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.
Emilie Goodyear, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid 0.05% & Ectoine 2.0% and Olopatadine hydrochloride ophthalmic solution 0.1% in people with Conjunctivitis, Allergic and Conjunctivitis, Vernal, run by Michael Marchand, MD at 1 site in Canada.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Oct 2022. 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 Canada. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Marchand, MD (514-805-1247, mic9@sympatico.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs of conjunctival erythema (time frame: 56 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 NCT03186755, which also lists 35 linked publications.
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 26 Oct 2022.