Contact Lens DiscomfortPhase 2NCT03994406
Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
A Phase 2 study testing CLM2 topical gel in people with Contact Lens Discomfort and Contact Lens-induced Corneal Disorder, run by Glia, LLC at 1 site in United States.
Trial summary
This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Discomfort, Contact Lens-induced Corneal Disorder, Contact Lens Acute Red Eye
- What is being tested?
- CLM2 topical gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to 30 Oct 2019
- 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
- Male or female of any race ≥18 years of age at Visit 1 Screening.
- Has provided verbal and written informed consent.
- Be able and willing to follow instructions, including participation in all study assessments and visits.
- Has been wearing soft contact lens in both eyes at least 2 days per week for at least a month.
- Duration of comfortable lens wear daily is less than desired.
- Suffers from at least two other symptoms while wearing lens with contact lens discomfort of grade 2 or higher:
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- Dryness.
- Grittiness
- Blurred vision
- Itching
- Conjunctival redness
- Burning
- Stinging.
- Lens awareness
- Use of artificial tears or gels two or more times a day during contact lens wear hours.
- Berkeley Dry Eye Flow Chart (DEFC) score ≥3.
Who cannot join
- BCVA at baseline <20/40.
- Wearing contact lens only in one eye.
- Wearers of the following contact lenses: Extended wear, prosthetic, scleral, and intracorneal gas permeable.
- Pregnant women or women of childbearing potential who are not using contraception.
- Diagnosis of the following autoimmune diseases: Addison's disease, Grave's disease, Hashimoto's thyroiditis, lupus, and Sjogren's syndrome.
- Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such dystrophies, infections, etc.
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- Has a condition or be in a situation that, the opinion of the investigator, that may interfere significantly with the subject's participation in the study. No active ocular condition or disease.
- Has a known adverse reaction and/or sensitivity to either study drug or its components.
- Unwilling to remove contact lens overnight.
- Unwilling to attempt to wear contact lens seven (7) days a week during the study period.
- Plan to change brand of contact lens during study period.
- Unwilling to wear contact lens for at least 10 hours if comfort permits, or until discomfort requires removal of contact lens prior to 10 hours.
- Unwilling to discontinue swimming with immersed head for the duration of the study.
- Unwilling to withhold the use of artificial tears, gels, or wetting agents during periods when contact lens is worn during the study period.
- Cannot withhold the following medications during the study period:
- antihistamines, some diuretics, antidepressants, antipsychotics, Restasis, Xiidra, Accutane, glaucoma medications, other anti-cholinergics; as well as gabapentin.
- Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Berkeley Clinical Research Center
Berkeley, California, 94720-2020
About this study
Official title: A Controlled Phase 2 Study for Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.
Read the detailed description
The clinical hypothesis is that CLM2 topical gel applied dermally on the forehead twice daily will be more effective than placebo (a) in reducing or eliminating ocular discomfort associated with contact lens wear, (b) prolong hours of comfortable wear, (c) prolong total hours of contact lens wear, (d) improve ease of insertion and removal of contact lens, and ( c) reduces friction between cornea/lens and lens/eyelid, without use of artificial eye drops or gels. One mechanism supporting this hypothesis is preliminary evidence of increased meibum secretion following CLM2 topical gel application.
- Conditions
- Contact Lens Discomfort, Contact Lens-induced Corneal Disorder, Contact Lens Acute Red Eye, Contact Lens-induced Corneal Fluorescein Staining
- Being tested
- CLM2 topical gel, Placebo topical gel
- Keywords
- contact lens, ocular erythema, contact lens discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLM2 topical gelDrug
Active topical gel for forehead dermal application
Placebo topical gelDrug
Placebo topical gel for forehead dermal application
| Study group | Role | What they receive |
|---|---|---|
| CLM2 Topical Gel | Experimental | CLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime. Receives: Drug: CLM2 topical gel |
| Placebo Topical Gel | Placebo comparator | Placebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime. Receives: Drug: Placebo topical gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours of continuous comfortable contact lens wear
Change in total hours per day
Measured: 21 days
Contact Lens Questionnaire-8 (CLDEQ-8)
Change in total score (0-37 worst)
Measured: 21 days
Berkeley Dry Eye Flow Chart
Change in grade (1-5 worst)
Measured: 21 days
Fluorescein corneal staining
Change in score (0-3 worst)
Measured: 21 days
Secondary outcomes (13)
Eye discomfort from CLDEQ-8, frequency
Change in score (0-4 worst)
Measured: 21 days
Eye discomfort from CLDEQ-8, intensity
Change in score (0-5 worst)
Measured: 21 days
Glia contact lens symptoms questionnaire
Change in total score (0-64)
Measured: 21 days
Fluorescein conjunctival staining
Change in conjunctival staining (0-3 worst)
Measured: 21 days
Tear film examination by TearScan
Change in total score (0-3 best)
Measured: 60-80 minutes
Tear film examination by TearScan
Change in total score (0-3 best)
Measured: 21 days
Tear film breakup time
Change in score (seconds)
Measured: 60-80 minutes
Tear film breakup time
Change in score (seconds)
Measured: 21 days
Tear meniscus height
Change in height (mm)
Measured: 60-80 minutes
Tear meniscus height
Change in height (mm)
Measured: 21 days
Visual acuity
Change in visual acuity
Measured: 21 days
Tear osmolarity
Change in tear osmolarity (mOsm/L)
Measured: 21 days
Schirmer test
Change in wetting length (mm)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start27 Jun 2019
- Primary completion30 Aug 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens DiscomfortStudies 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
- Model description
- 1:1, study drug:placebo; block design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glia, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meng C. Lin, OD,PhD,FAAO, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994406
- Sponsor's protocol ID
- CLM-1
- Status last verified
- Mar 2023
- First submitted
- 20 Jun 2019
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Phase 2 Study for Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
- ClinicalTrials.gov ID
- NCT03994406
- Acronym / sponsor ID
- CLM-1
- Conditions
- Contact Lens Discomfort, Contact Lens-induced Corneal Disorder, Contact Lens Acute Red Eye, Contact Lens-induced Corneal Fluorescein Staining
- Keywords
- contact lens, ocular erythema, contact lens discomfort
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Glia, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 21 Jun 2019 (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 contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.
Detailed description
The clinical hypothesis is that CLM2 topical gel applied dermally on the forehead twice daily will be more effective than placebo (a) in reducing or eliminating ocular discomfort associated with contact lens wear, (b) prolong hours of comfortable wear, (c) prolong total hours of contact lens wear, (d) improve ease of insertion and removal of contact lens, and ( c) reduces friction between cornea/lens and lens/eyelid, without use of artificial eye drops or gels. One mechanism supporting this hypothesis is preliminary evidence of increased meibum secretion following CLM2 topical gel application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1, study drug:placebo; block design.
| Arm | Type | Receives |
|---|---|---|
| CLM2 Topical Gel | Experimental | Drug: CLM2 topical gelCLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime. |
| Placebo Topical Gel | Placebo comparator | Drug: Placebo topical gelPlacebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female of any race ≥18 years of age at Visit 1 Screening.
- Has provided verbal and written informed consent.
- Be able and willing to follow instructions, including participation in all study assessments and visits.
- Has been wearing soft contact lens in both eyes at least 2 days per week for at least a month.
- Duration of comfortable lens wear daily is less than desired.
Key exclusion criteria (17 listed)
- BCVA at baseline <20/40.
- Wearing contact lens only in one eye.
- Wearers of the following contact lenses: Extended wear, prosthetic, scleral, and intracorneal gas permeable.
- Pregnant women or women of childbearing potential who are not using contraception.
- Diagnosis of the following autoimmune diseases: Addison's disease, Grave's disease, Hashimoto's thyroiditis, lupus, and Sjogren's syndrome.
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 |
|---|---|---|
| CLM2 topical gelActive topical gel for forehead dermal application | Drug | CLM2 Topical Gel |
| Placebo topical gelPlacebo topical gel for forehead dermal application | Drug | Placebo Topical Gel |
Primary outcome
Hours of continuous comfortable contact lens wear
Time frame: 21 days
Change in total hours per day
Contact Lens Questionnaire-8 (CLDEQ-8)
Time frame: 21 days
Change in total score (0-37 worst)
Berkeley Dry Eye Flow Chart
Time frame: 21 days
Change in grade (1-5 worst)
Fluorescein corneal staining
Time frame: 21 days
Change in score (0-3 worst)
13 secondary outcomes
Eye discomfort from CLDEQ-8, frequency
Time frame: 21 days
Eye discomfort from CLDEQ-8, intensity
Time frame: 21 days
Glia contact lens symptoms questionnaire
Time frame: 21 days
Fluorescein conjunctival staining
Time frame: 21 days
Tear film examination by TearScan
Time frame: 60-80 minutes
Tear film examination by TearScan
Time frame: 21 days
Tear film breakup time
Time frame: 60-80 minutes
Tear film breakup time
Time frame: 21 days
Tear meniscus height
Time frame: 60-80 minutes
Tear meniscus height
Time frame: 21 days
Visual acuity
Time frame: 21 days
Tear osmolarity
Time frame: 21 days
Schirmer test
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- 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.
Meng C. Lin, OD,PhD,FAAO principal investigator
University of California, Berkeley
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 CLM2 topical gel in people with Contact Lens Discomfort and Contact Lens-induced Corneal Disorder, run by Glia, LLC 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 16 inclusion and 17 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 Mar 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hours of continuous comfortable contact lens wear (time frame: 21 days). The study lists 4 primary outcomes in all. 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 Mar 2023.