Dry EyePhase 2NCT00840268
A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients
A Phase 2 study testing Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel in people with Dry Eye, run by Alcon Research.
Trial summary
The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) ophthalmic gel compared to Vehicle for 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?
- Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 427 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jul 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
- Must read, sign, and date an informed consent document and HIPAA privacy document.
- Diagnosis of dry eye at Visit 1 (Day 0).
- Able and willing to follow study instructions.
- Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Diagnosis of Sjogren's syndrome (or suspected to have Sjogren's syndrome).
- History or evidence of ocular or intraocular surgery in either eye within the previous year.
- History or evidence of serious ocular trauma in either eye within the previous 6 months.
- History or evidence of corneal transplant or transplant variant procedures.
- History of intolerance or hypersensitivity to any component of the study medications.
- History of glaucoma or current ocular hypertension in either eye, or treatment for either condition within 6 months prior to Visit 1.
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- History or evidence of corneal conditions, other than dry eye, that may affect the corneal structure.
- Use of any concomitant topical ocular medications including artificial tears during the study period.
- Females of childbearing potential if breastfeeding, unwilling to undergo urine pregnancy test at screening and upon exiting the study, have a positive urine pregnancy test at screening, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study.
- Use of RESTASIS® 0.05% or an ocular steroid within 30 days of Visit 1.
- Use of systemic medications that have not been stable for 30 days prior to Visit 1.
- Any ocular condition that may preclude the safe administration of the test article.
- Unwilling to discontinue contact lens wear at least 4 weeks prior to Visit 1, and during the study period.
- Use of punctal plugs or punctal cautery.
- Use of lid scrubs/warm compresses within 14 days of Visit 1.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) ophthalmic gel compared to Vehicle for the treatment of dry eye.
Read the detailed description
A 7-day Vehicle pre-randomization (run-in) phase during which all patients will receive 1 drop of Vehicle in each eye twice daily will precede the 21-day treatment phase, for an overall study duration of 28 days.
- Conditions
- Dry Eye
- Being tested
- Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel, Hydroxypropyl Guar Galactomannan Vehicle
- Keywords
- OSDI, corneal staining, Dry Eye, Dry Eye Signs and Symptoms in Dry Eye Patients
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gelDrug
Also called HPGG
Hydroxypropyl Guar Galactomannan VehicleDrug
Also called HPGG Vehicle
Inactive ingredients used as a placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| HPGG 0.25% | Experimental | Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase). Receives: Drug: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel |
| HPGG Vehicle | Placebo comparator | Hydroxypropyl Guar Galactomannan Vehicle, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase). Receives: Drug: Hydroxypropyl Guar Galactomannan Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in sodium fluorescein corneal staining score
Measured: Baseline (Day 7), Up to Day 28
Secondary outcomes (1)
Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score
Measured: Baseline (Day 7), Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay H. Mashburn, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840268
- Sponsor's protocol ID
- C-08-34
- Status last verified
- Jul 2014
- First submitted
- 6 Feb 2009
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients
- ClinicalTrials.gov ID
- NCT00840268
- Acronym / sponsor ID
- C-08-34
- Conditions
- Dry Eye
- Keywords
- OSDI, corneal staining, Dry Eye, Dry Eye Signs and Symptoms in Dry Eye Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Feb 2009 (estimated)
- 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 demonstrate efficacy of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) ophthalmic gel compared to Vehicle for the treatment of dry eye.
Detailed description
A 7-day Vehicle pre-randomization (run-in) phase during which all patients will receive 1 drop of Vehicle in each eye twice daily will precede the 21-day treatment phase, for an overall study duration of 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPGG 0.25% | Experimental | Drug: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gelHydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase). |
| HPGG Vehicle | Placebo comparator | Drug: Hydroxypropyl Guar Galactomannan VehicleHydroxypropyl Guar Galactomannan Vehicle, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must read, sign, and date an informed consent document and HIPAA privacy document.
- Diagnosis of dry eye at Visit 1 (Day 0).
- Able and willing to follow study instructions.
- Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (16 listed)
- Diagnosis of Sjogren's syndrome (or suspected to have Sjogren's syndrome).
- History or evidence of ocular or intraocular surgery in either eye within the previous year.
- History or evidence of serious ocular trauma in either eye within the previous 6 months.
- History or evidence of corneal transplant or transplant variant procedures.
- History of intolerance or hypersensitivity to any component of the study medications.
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 |
|---|---|---|
| Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gelAlso: HPGG | Drug | HPGG 0.25% |
| Hydroxypropyl Guar Galactomannan VehicleAlso: HPGG VehicleInactive ingredients used as a placebo comparator | Drug | HPGG Vehicle |
Primary outcome
Mean change from baseline in sodium fluorescein corneal staining score
Time frame: Baseline (Day 7), Up to Day 28
1 secondary outcome
Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score
Time frame: Baseline (Day 7), Up to Day 28
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 17 Jul 2014.
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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.
Jay H. Mashburn study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel in people with Dry Eye, run by Alcon Research.
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 5 inclusion and 16 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 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean change from baseline in sodium fluorescein corneal staining score (time frame: Baseline (Day 7), Up to Day 28). 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 17 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.