Dry EyePhase 2NCT03693183
Efficacy Study of Ketorolac and HPMC to Treat Dry Eye
A Phase 2 study testing Ketorolac/HPMC and HPMC in people with Dry Eye, run by ORA, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether ketorolac and Hydroxypropyl Methylcellulose are effective in the treatment of Dry Eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Ketorolac/HPMC and HPMC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to 15 Jun 2009
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent;
- Are 18 years of age or older;
- Are able and willing to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;
- Have a corrected visual acuity LogMar +0.7 (ETDRS) or better in each eye;
- Have a reported history of dry eye in each eye;
- Have a history of use of or a desire to use an eye drop for dry eye symptoms within the past 6 months;
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- Have a central corneal sensitivity score greater than 55 mm in each eye at Visit 1;
- Have an average diary reported score for ocular discomfort, burning, dryness, grittiness, or stinging of ≥ 1.5 during the one week run-in period between Visits 1 and 2;
- Have a greater than or equal to 1 fluorescein staining score in any region in at least one eye prior to exposure to the CAE at Visit 1;
- Report greater than or equal 3 in worst symptom for all diary entries between visits 2 and 3
- If female and of childbearing potential. Are not pregnant, nursing, or planning a pregnancy. Women of childbearing potential are required to have a negative urine pregnancy test at the screening and exit visits and agree to use an acceptable method of contraception for the duration of the study.
Who cannot join
- Have contraindications to the use of the study medication(s);
- Have a known allergy or sensitivity to the study medication(s) or their components;
- Have anterior blepharitis, which is deemed clinically significant and/or likely to interfere with study parameters in the opinion of the investigator;
- Are diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis);
- Wear contact lenses within 1 week of Visit 1 or throughout the duration of the study;
- Have previously had laser in situ keratomileusis (LASIK) surgery;
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- Are currently taking any topical ophthalmic prescriptions or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and cannot discontinue these medications 2 hours prior to Visit 1 and for the duration of the trial;
- Have used Restasis® within 30 days of Visit 1;
- Have a systemic disease, or uncontrolled medical condition, that in the opinion of the investigator could interfere with study measurements or subject compliance;
- Are currently taking (at Visit 1) any medication known to cause ocular drying that has not been used on a stable dosing regimen for 30 days prior to Visit 1;
- Are currently pregnant, nursing, or planning a pregnancy;
- (For women of childbearing potential) Are unwilling to submit a urine sample for a pregnancy test at Visit 1 and at exit visit;
- Have received another experimental drug or device within 30 days of Visit 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Reserach Associates
Andover, Massachusetts, 01810
About this study
Official title: A Double-Masked, Randomized, Single-Center Study Evaluating the Effect of 0.30% Ketorolac/0.80% HPMC, 0.80% HPMC and Vehicle on Symptoms of Dry Eye After Exposure to the Controlled Adverse Environment (CAE)
The purpose of this study is to determine whether ketorolac and Hydroxypropyl Methylcellulose are effective in the treatment of Dry Eye.
Read the detailed description
This is a double masked, randomized study with approximately 45 subjects randomized to one of the three treatment arms at a single site. There are 5 visits over the course of 16 days.
Visit 1: Day -7 Visit 2: Day 0 Visit 3: Day 2 Visit 4: Day 7 Visit 5: Day 9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac/HPMCDrug
Also called Ketorolac/Hydroxypropyl Methylcellulose
0.30% Ketorolac/0.80%HPMC Ophthalmic solution administered 4 times per day for 2 days
HPMCDrug
Also called Hydroxypropyl Methylcellulose
0.80% Hydroxypropyl Methylcellulose solution 4 times per day for 2 days
VehicleDrug
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac/HPMC | Experimental | Drug: Ketorolac/HPMC Ophthalmic Solution
1 drop administered in each eye 4 times per day for 2 days Receives: Drug: Ketorolac/HPMC |
| HPMC | Active comparator | Drug: 0.80% Hydroxypropyl Methylcellulose(HMPC) Ophthalmic Solution
1 Drop administered in each eye 4 times per day for 2 days Receives: Drug: HPMC |
| Vehicle | Placebo comparator | Drug: Vehicle Ophthalmic Solution
1 drop administered in each eye 4 times a day for 2 days Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Ketorolac and HPMC on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.
Evaluate the symptoms of Ketorolac and HPMC on ocular discomfort in subjects with dry eye syndrome.
Measured: Day 0 through Day 9
Secondary outcomes (1)
Efficacy of Ketorolac and HPMC on fluorescein staining using the Ora Calibra® scale.
Evaluate fluorescein staining of Ketorolac and HPMC in subjects with dry eye syndrome.
Measured: Day 0 through Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study startMar 2009
- Primary completion15 Jun 2009
- Study completion15 Jun 2009
Why it stopped: Study terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H. Jerome Crampton, MD, Principal investigator, Ophthalmic Reserach Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693183
- Sponsor's protocol ID
- 09-004-02
- Status last verified
- Apr 2024
- First submitted
- 11 Nov 2015
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Single-Center Study Evaluating the Effect of 0.30% Ketorolac/0.80% HPMC, 0.80% HPMC and Vehicle on Symptoms of Dry Eye After Exposure to the Controlled Adverse Environment (CAE)
- ClinicalTrials.gov ID
- NCT03693183
- Acronym / sponsor ID
- 09-004-02
- Conditions
- Dry Eye
- Keywords
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- 15 Jun 2009 (actual)
- Study completion
- 15 Jun 2009 (actual)
- First posted
- 2 Oct 2018 (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.
The purpose of this study is to determine whether ketorolac and Hydroxypropyl Methylcellulose are effective in the treatment of Dry Eye.
Detailed description
This is a double masked, randomized study with approximately 45 subjects randomized to one of the three treatment arms at a single site. There are 5 visits over the course of 16 days.
Visit 1: Day -7 Visit 2: Day 0 Visit 3: Day 2 Visit 4: Day 7 Visit 5: Day 9
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketorolac/HPMC | Experimental | Drug: Ketorolac/HPMCDrug: Ketorolac/HPMC Ophthalmic Solution 1 drop administered in each eye 4 times per day for 2 days |
| HPMC | Active comparator | Drug: HPMCDrug: 0.80% Hydroxypropyl Methylcellulose(HMPC) Ophthalmic Solution 1 Drop administered in each eye 4 times per day for 2 days |
| Vehicle | Placebo comparator | Drug: VehicleDrug: Vehicle Ophthalmic Solution 1 drop administered in each eye 4 times a day for 2 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide written informed consent;
- Are 18 years of age or older;
- Are able and willing to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;
- Have a corrected visual acuity LogMar +0.7 (ETDRS) or better in each eye;
- Have a reported history of dry eye in each eye;
Key exclusion criteria (13 listed)
- Have contraindications to the use of the study medication(s);
- Have a known allergy or sensitivity to the study medication(s) or their components;
- Have anterior blepharitis, which is deemed clinically significant and/or likely to interfere with study parameters in the opinion of the investigator;
- Are diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis);
- Wear contact lenses within 1 week of Visit 1 or throughout the duration of 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 |
|---|---|---|
| Ketorolac/HPMCAlso: Ketorolac/Hydroxypropyl Methylcellulose0.30% Ketorolac/0.80%HPMC Ophthalmic solution administered 4 times per day for 2 days | Drug | Ketorolac/HPMC |
| HPMCAlso: Hydroxypropyl Methylcellulose0.80% Hydroxypropyl Methylcellulose solution 4 times per day for 2 days | Drug | HPMC |
| VehicleVehicle | Drug | Vehicle |
Primary outcome
Efficacy of Ketorolac and HPMC on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.
Time frame: Day 0 through Day 9
Evaluate the symptoms of Ketorolac and HPMC on ocular discomfort in subjects with dry eye syndrome.
1 secondary outcome
Efficacy of Ketorolac and HPMC on fluorescein staining using the Ora Calibra® scale.
Time frame: Day 0 through Day 9
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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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.
H. Jerome Crampton, MD principal investigator
Ophthalmic Reserach Associates
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 Ketorolac/HPMC and HPMC in people with Dry Eye, run by ORA, Inc. 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 11 inclusion and 13 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: withdrawn, as of the sponsor's last update on 24 Apr 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of Ketorolac and HPMC on ocular discomfort using the Ora Calibra® Ocular Discomfort scale. (time frame: Day 0 through Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.