A Phase 3 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Vehicle Ophthalmic Solution in Allergic Conjunctivitis, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 3, Interventional, and Treatment
The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Vehicle-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC).
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 95 is close to the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Aldeyra Therapeutics, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 25 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Vehicle Ophthalmic Solution
Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.
Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.
Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber
Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
Time frame: The efficacy assessment period was 110 to 210 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.
Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = none, 4 = extremely severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
Time frame: The efficacy assessment period was 12 to 212 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.
| Milestone | Reproxalap (0.25%), Then Vehicle | Vehicle, Then Reproxalap (0.25%) |
|---|---|---|
| Started | 48 | 47 |
| Completed | 46 | 43 |
| Not completed | 2 | 4 |
Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
| score on a scale | Reproxalap (0.25%) | Vehicle |
|---|---|---|
| Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber | 0.94 ± 0.08 | 1.38 ± 0.08 |
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = none, 4 = extremely severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
| score on a scale | Reproxalap (0.25%) | Vehicle |
|---|---|---|
| Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber | 0.51 ± 0.03 | 0.65 ± 0.03 |
Collected over The period of time over which adverse events were collected was approximately one day for each intervention.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reproxalap (0.25%) | 0/91 (0%) | 0/91 (0%) | 69/91 (75.8%) |
| Vehicle | 0/93 (0%) | 0/93 (0%) | 6/93 (6.5%) |
| Event | Reproxalap (0.25%) | Vehicle |
|---|---|---|
| General disorders and administrations site conditionsGeneral disorders | 68/91 | 6/93 |
| Eye disodersEye disorders | 8/91 | 0/93 |
| Age, Continuous(years) | Reproxalap (0.25%), Then Vehicle | Vehicle, Then Reproxalap (0.25%) | Total |
|---|---|---|---|
| Mean | 40.3 ± 13.41 | 41.9 ± 11.13 | 41.1 ± 12.29 |
| Sex: Female, Male(Participants) | Reproxalap (0.25%), Then Vehicle | Vehicle, Then Reproxalap (0.25%) | Total |
|---|---|---|---|
| Female | 26 | 27 | 53 |
| Male | 22 | 20 | 42 |
| Ethnicity (NIH/OMB)(Participants) | Reproxalap (0.25%), Then Vehicle | Vehicle, Then Reproxalap (0.25%) | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 44 | 45 | 89 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Reproxalap (0.25%), Then Vehicle | Vehicle, Then Reproxalap (0.25%) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 7 | 17 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 9 | 19 |
| White | 25 | 30 | 55 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Reproxalap